The following data is part of a premarket notification filed by Cosmed S.r.l. with the FDA for Cosmed Microquark.
| Device ID | K020745 |
| 510k Number | K020745 |
| Device Name: | COSMED MICROQUARK |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | COSMED S.R.L. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff COSMED S.R.L. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-07 |
| Decision Date | 2003-01-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18052400180034 | K020745 | 000 |