Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate
FDA 510(k) K111773 · Renu Medical, Inc.
510(k) numberK111773
Submission
- Device name
- Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate
- Applicant
- Renu Medical, Inc.
Everett, WA, US - Received
- June 23, 2011
- Decision date
- November 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLF – Oximeter, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Other 510(k)s with product code NLF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…NLF · Traditional | Stryker Sustainability Solutions | 10/22/2024SE |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…NLF · Traditional | Stryker Sustainability Solutions | 12/04/2022SE |
| K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)…NLF · Traditional | Stryker Sustainability Solutions | 03/08/2022SE |
| K201699 | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorNLF · Special | Surgical Instrument and Savings Inc (Dba Medline… | 07/22/2020SE |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsNLF · Traditional | Surgical Instrument Service and Savings, Inc. | 07/03/2019SE |
| K110723 | M-Lncs Oximetry Sensors, Reprocessed M-Lncs Oximetry SensorsNLF · Special | Masimo Corporation | 07/28/2011SE |
| K102560 | Reprocessed Pulse Oximeter SensorsNLF · Traditional | Sterilmed, Inc. | 02/18/2011SE |
| K101280 | Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeNLF · Traditional | Midwest Reprocessing Center, LLC | 10/07/2010SE |
| K092368 | Reprocessed Pulse Oximeter SensorsNLF · Traditional | Sterilmed, Inc. | 11/03/2009SE |
| K083719 | LNCS Oximetry SensorsNLF · Traditional | Masimo Corporation | 07/30/2009SE |
More from Masimo Corporation
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|---|---|---|
| K203847 | Reprocessed Tri Pulse Compression GarmentJOW · Traditional | 05/07/2021SE |
| K121145 | Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical…JOW · Traditional | 06/12/2012SE |
| K093658 | Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot…JOW · Traditional | 01/14/2010SE |
| K081927 | Renu Medical Oximetry Sensor, Adult, Ped, Inf,NeoNLF · Traditional | 02/06/2009SE |
| K072194 | Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25NLF · Traditional | 11/29/2007SE |
| K063661 | Renu Reprocessed Nellcor Oxysensor, Models D-20 and I-20NLF · Traditional | 05/25/2007SE |
| K051227 | Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1JOW · Traditional | 04/07/2006SE |
| K031559 | Renu Medical Reporcessed Compressible Limb SleevesJOW · Traditional | 11/12/2003SE |
Questions and answers
When was Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate cleared by the FDA?
Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate (K111773) received a 510(k) decision of Substantially Equivalent on November 16, 2011, 146 days after the submission was received.
What is the product code of K111773?
The FDA product code is NLF – Oximeter, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.2700.