Ysi Model 801
FDA 510(k) K865012 · Yellow Springs Instrument Co., Inc.
510(k) numberK865012
Submission
- Device name
- Ysi Model 801
- Applicant
- Yellow Springs Instrument Co., Inc.
Yellow Springs, OH, US - Received
- December 23, 1986
- Decision date
- March 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
Other 510(k)s with product code FMT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243606 | Babyroo TN300FMT · Traditional | Draeger Medical Systems, Inc. | 01/17/2025SE |
| K230278 | Babyroo TN300FMT · Traditional | Draeger Medical Systems, Inc. | 05/30/2023SE |
| K213551 | Giraffe Omnibed Carestation CS1FMT · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
| K201628 | Panda iRes Warmer, Giraffe WarmerFMT · Traditional | GE Healthcare | 02/12/2021SE |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface…FMT · Traditional | Deroyal Industries, Inc. | 04/02/2020SE |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe CoverFMT · Traditional | Deroyal Industries, Inc. | 01/21/2020SE |
| K173516 | NuBorne Infant WarmerFMT · Abbreviated | International Biomedical | 08/17/2018SE |
| K123309 | Giraffe and Panda WarmersFMT · Traditional | Ohmeda Medical | 02/05/2013SE |
| K120642 | Resuscitaire with AutobreathFMT · Traditional | Draeger Medical Systems, Inc. | 11/02/2012SE |
| K122267 | Giraffe and Panda WarmersFMT · Special | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 10/02/2012SE |
More from Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K962070 | Ysi 400 Series Atuoclavable Reusable Temperature ProbeFLL · Traditional | 07/19/1996SE |
| K922821 | Ysi Models 4700 Foley Catheter Temperature ProbesEZL · Traditional | 11/23/1992SE |
| K922007 | Ysi Model 441A Airway Temperature ProbeBZT · Traditional | 11/04/1992SE |
| K910633 | Ysi Model 1500 Blood Glucose AnalyzerCGA · Traditional | 04/12/1991SE |
| K910718 | Ysi Precision 4000 ThermometerFLL · Traditional | 04/09/1991SE |
| K901131 | Ysi Model 1500 Sport L-Lactate AnalyzerKHP · Traditional | 08/27/1990SN |
| K893409 | Ysi Models 4400 & 4700 Esophageal Stethoscope TempBZT · Traditional | 07/20/1989SE |
| K891480 | Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerCGA · Traditional | 05/22/1989SE |
| K883793 | Disposable Temperature Probes (Several Models)FLL · Traditional | 11/21/1988SE |
| K853551 | Ysi Model 790 Tele-ThermometerFLL · Traditional | 09/19/1985SE |
Questions and answers
When was Ysi Model 801 cleared by the FDA?
Ysi Model 801 (K865012) received a 510(k) decision of Substantially Equivalent on March 4, 1987, 71 days after the submission was received.
What is the product code of K865012?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.