Nicu V'02
FDA 510(k) K190561 · Cosmed Nordic Aps
510(k) numberK190561
Submission
- Device name
- Nicu V'02
- Applicant
- Cosmed Nordic Aps
Odense, DK - Received
- March 5, 2019
- Decision date
- September 4, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZL – Computer, Oxygen-Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1730
- Specialty
- Anesthesiology
Other 510(k)s with product code BZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200076 | Breezing MedBZL · Traditional | Tf Health Co. | 09/25/2020SE |
| K110810 | Anascient Breath MonitorBZL · Traditional | Invoy Technologies, LLC | 06/21/2011SE |
| K093080 | Metaphor Metabolic MonitorBZL · Traditional | Treymed, Inc. | 01/22/2010SE |
| K071533 | Fitmate SeriesBZL · Traditional | Cosmed Srl | 09/28/2007SE |
| K070858 | Express SeriesBZL · Special | Medical Graphics Corp. | 04/16/2007SE |
| K061731 | Medgraphics Ultima SystemBZL · Special | Medical Graphics Corp. | 09/06/2006SE |
| K021490 | Reevue Indirect Calorimeter, MODEL#8100BZL · Traditional | Korr Medical Technologies, Inc. | 01/02/2003SE |
| K021605 | MedgemBZL · Special | Healthetech, Inc. | 06/14/2002SE |
| K010577 | Bodygem, Model HB211BZL · Traditional | Healthetech, Inc. | 01/10/2002SE |
| K954731 | Oxylog 2BZL · Traditional | P.K. Morgan , Ltd. | 01/06/1997SE |
Questions and answers
When was Nicu V'02 cleared by the FDA?
Nicu V'02 (K190561) received a 510(k) decision of Substantially Equivalent on September 4, 2020, 549 days after the submission was received.
What is the product code of K190561?
The FDA product code is BZL – Computer, Oxygen-Uptake, a Class II (moderate risk) device regulated under 21 CFR 868.1730.