K162515 is an FDA 510(k) clearance for the COSMED K5 Wearable Metabolic Technology. This device is classified as a Calculator, Pulmonary Function Data (Class II - Special Controls, product code BZC).
Submitted by Cosmed Srl (Pavona Di Albano Rome, IT). The FDA issued a Cleared decision on June 20, 2017, 285 days after receiving the submission on September 8, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1880.
| 510(k) Number | K162515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2016 |
| Decision Date | June 20, 2017 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZC - Calculator, Pulmonary Function Data |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1880 |