The following data is part of a premarket notification filed by Cosmed S.r.l. with the FDA for Fitmate Series.
| Device ID | K071533 |
| 510k Number | K071533 |
| Device Name: | FITMATE SERIES |
| Classification | Computer, Oxygen-uptake |
| Applicant | COSMED S.R.L. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07000 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff COSMED S.R.L. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07000 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-05 |
| Decision Date | 2007-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18052400180362 | K071533 | 000 |
| 18052400180249 | K071533 | 000 |
| 18052400180225 | K071533 | 000 |
| 18052400180201 | K071533 | 000 |