The following data is part of a premarket notification filed by Schiller Ag with the FDA for Cardiovit Cv-3.
Device ID | K841254 |
510k Number | K841254 |
Device Name: | CARDIOVIT CV-3 |
Classification | Electrocardiograph |
Applicant | SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341 |
Contact | Peter Weber |
Correspondent | Peter Weber 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 | 1984-03-26 |
Decision Date | 1985-01-24 |