The following data is part of a premarket notification filed by Schiller Ag with the FDA for Cardiovit At-102 G2.
| Device ID | K183425 |
| 510k Number | K183425 |
| Device Name: | CARDIOVIT AT-102 G2 |
| Classification | Electrocardiograph |
| Applicant | Schiller AG Altgasse 68 Baar Zug, CH 6341 |
| Contact | Sabina Standiford |
| Correspondent | Ray Kelly Arazy Group Consultants Inc. 68 Southwood Terrace Southbury, CT 06488 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-11 |
| Decision Date | 2020-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613365001860 | K183425 | 000 |
| 07613365002232 | K183425 | 000 |
| 07613365002775 | K183425 | 000 |
| 07613365003291 | K183425 | 000 |
| 07613365003802 | K183425 | 000 |
| 07613365000207 | K183425 | 000 |
| 07613365000214 | K183425 | 000 |
| 07613365002218 | K183425 | 000 |
| 07613365003772 | K183425 | 000 |
| 07613365002201 | K183425 | 000 |