The following data is part of a premarket notification filed by Cosmed S.r.l. with the FDA for Cosmed Quark C12/quark T12.
| Device ID | K014262 |
| 510k Number | K014262 |
| Device Name: | COSMED QUARK C12/QUARK T12 |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-27 |
| Decision Date | 2002-03-26 |