Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax Sensors; Midwest Re
FDA 510(k) K111007 · Midwest Reprocessing Center, LLC
510(k) numberK111007
Submission
- Device name
- Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax Sensors; Midwest Re
- Applicant
- Midwest Reprocessing Center, LLC
Birmingham, AL, US - Received
- April 11, 2011
- Decision date
- June 8, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NMD – Oximeter, Tissue Saturation, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
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 NMD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100523 | Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model…NMD · Traditional | Hygia Health Services, Inc. | 05/04/2010SE |
More from Hygia Health Services, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K101280 | Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeNLF · Traditional | 10/07/2010SE |
| K101702 | Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsJOW · Traditional | 08/27/2010SE |
| K101330 | Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…JOW · Traditional | 08/27/2010SE |
Questions and answers
When was Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax Sensors; Midwest Re cleared by the FDA?
Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax Sensors; Midwest Re (K111007) received a 510(k) decision of Substantially Equivalent on June 8, 2011, 58 days after the submission was received.
What is the product code of K111007?
The FDA product code is NMD – Oximeter, Tissue Saturation, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.2700.