The following data is part of a premarket notification filed by Cosmed S.r.l. with the FDA for Cosmed K4.
| Device ID | K963373 |
| 510k Number | K963373 |
| Device Name: | COSMED K4 |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | COSMED S.R.L. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Anne Marie Cesario |
| Correspondent | Anne Marie Cesario COSMED S.R.L. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-27 |
| Decision Date | 1997-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18052400180157 | K963373 | 000 |
| 18052400180126 | K963373 | 000 |