The following data is part of a premarket notification filed by Schiller Ag with the FDA for Cardiovit At-102.
| Device ID | K031557 |
| 510k Number | K031557 |
| Device Name: | CARDIOVIT AT-102 |
| Classification | Electrocardiograph |
| Applicant | SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341 |
| Contact | Markus Buetler |
| Correspondent | Markus Buetler SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2004-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613365001686 | K031557 | 000 |
| 07613365000078 | K031557 | 000 |
| 07613365000061 | K031557 | 000 |
| 07613365000030 | K031557 | 000 |
| 07613365000023 | K031557 | 000 |