FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
COSMED K5 Wearable Metabolic Technology
K Number: K162515
·
Decision Jun 20, 2017
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
10
Review Days
285
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Basic Information
- Device Name
- COSMED K5 Wearable Metabolic Technology
- K Number
- K162515
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cosmed Srl
- Date Received
- September 8, 2016
- Decision Date
- June 20, 2017
- Product Code
- BZC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
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Other Clearances by Cosmed Srl
| K Number | Device Name | ||
|---|---|---|---|
| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | Feb 6, 2020 | Substantially Equivalent |
| K120146 | QUARK SERIES | Dec 11, 2012 | Substantially Equivalent |
| K093174 | SPIROPALM | Feb 26, 2010 | Substantially Equivalent |
| K071533 | FITMATE SERIES | Sep 28, 2007 | Substantially Equivalent |
| K040549 | COSMED PONY FX | Sep 28, 2004 | Substantially Equivalent |
| K020745 | COSMED MICROQUARK | Jan 2, 2003 | Substantially Equivalent |
| K014262 | COSMED QUARK C12/QUARK T12 | Mar 26, 2002 | Substantially Equivalent |
| K001174 | COSMED QUARK | Jan 11, 2001 | Substantially Equivalent |
| K963373 | COSMED K4 | Sep 10, 1997 | Substantially Equivalent |