The following data is part of a premarket notification filed by Cosmed Srl with the FDA for Cosmed Q-nrg / Q-nrg+ Portable Metabolic Monitors.
| Device ID | K190800 |
| 510k Number | K190800 |
| Device Name: | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | Cosmed Srl Vi Dei Piani Di Monte Savello 37, Albano Laziale Rome, IT 0041 |
| Contact | Andrea Duca |
| Correspondent | Roger Gray Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, IT 00153 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-28 |
| Decision Date | 2020-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18052400180539 | K190800 | 000 |
| 18052400180522 | K190800 | 000 |