The following data is part of a premarket notification filed by Schiller America, Inc. with the FDA for Cardiovit At-1, P-80.
| Device ID | K946205 |
| 510k Number | K946205 |
| Device Name: | CARDIOVIT AT-1, P-80 |
| Classification | Electrocardiograph |
| Applicant | SCHILLER AMERICA, INC. 3002 DOW AVE., #138 Tustin, CA 92780 |
| Contact | Markua Martitz |
| Correspondent | Markua Martitz SCHILLER AMERICA, INC. 3002 DOW AVE., #138 Tustin, CA 92780 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-21 |
| Decision Date | 1995-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613365000214 | K946205 | 000 |
| 07613365000207 | K946205 | 000 |
| 07613365000009 | K946205 | 000 |
| 07613365002225 | K946205 | 000 |
| 07613365002218 | K946205 | 000 |