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 |