COSMED K5 Wearable Metabolic Technology
FDA 510(k) K162515 · Cosmed Srl
510(k) numberK162515
Submission
- Device name
- COSMED K5 Wearable Metabolic Technology
- Applicant
- Cosmed Srl
Pavona Di Albano Rome, IT - Received
- September 8, 2016
- Decision date
- June 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZC – Calculator, Pulmonary Function Data
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1880
- Specialty
- Anesthesiology
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| K183567 | Vyntus/SentrySuite Product LineBZC · Traditional | Vyaire Medical | 08/23/2019SE |
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| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…BZC · Traditional | Vyaire Medical, Inc. | 11/30/2018SE |
| K161295 | MiniBox +BZC · Traditional | Pulmone Advanced Medical Devices, Ltd. | 10/21/2016SE |
| K150810 | Vyntus / SentrySuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/14/2015SE |
| K133925 | Vyntus/ Sentrysuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/22/2014SE |
| K133051 | Pulmone Minibox PFT TMBZC · Traditional | Pulmone Advanced Medical Devices, Ltd. | 05/02/2014SE |
| K102047 | Lci Option for InnocorBZC · Traditional | Innovision A/S | 11/01/2011SE |
| K072323 | Masterscreen & Oxycon CPXBZC · Special | Viasys Healthcare GmbH | 10/10/2007SE |
More from Viasys Healthcare GmbH
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| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsBTY · Traditional | 02/06/2020SE |
| K120146 | Quark SeriesCBK · Traditional | 12/11/2012SE |
| K093174 | SpiropalmBZG · Traditional | 02/26/2010SE |
| K071533 | Fitmate SeriesBZL · Traditional | 09/28/2007SE |
| K040549 | Cosmed Pony FXBTY · Traditional | 09/28/2004SE |
| K020745 | Cosmed MicroquarkBTY · Traditional | 01/02/2003SE |
| K014262 | Cosmed Quark C12/QUARK T12DPS · Traditional | 03/26/2002SE |
| K001174 | Cosmed QuarkBZC · Traditional | 01/11/2001SE |
| K963373 | Cosmed K4BZC · Traditional | 09/10/1997SE |
Questions and answers
When was COSMED K5 Wearable Metabolic Technology cleared by the FDA?
COSMED K5 Wearable Metabolic Technology (K162515) received a 510(k) decision of Substantially Equivalent on June 20, 2017, 285 days after the submission was received.
What is the product code of K162515?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.