FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
K Number: K190800
·
Decision Feb 6, 2020
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
10
Review Days
315
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Basic Information
- Device Name
- Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
- K Number
- K190800
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cosmed Srl
- Date Received
- March 28, 2019
- Decision Date
- February 6, 2020
- Product Code
- BTY
- 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
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Other Clearances by Cosmed Srl
| K Number | Device Name | ||
|---|---|---|---|
| K162515 | COSMED K5 Wearable Metabolic Technology | Jun 20, 2017 | 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 |