The following data is part of a premarket notification filed by Cosmed S.r.l. with the FDA for Cosmed K5 Wearable Metabolic Technology.
| Device ID | K162515 |
| 510k Number | K162515 |
| Device Name: | COSMED K5 Wearable Metabolic Technology |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | COSMED S.r.l. Via Dei Piani Di Monte Savello, 37 Pavona Di Albano Rome, IT 00041 |
| Contact | Andrea Duca |
| Correspondent | Roger Gray Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, IT 00153 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-08 |
| Decision Date | 2017-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18052400180485 | K162515 | 000 |