The following data is part of a premarket notification filed by Schiller Ag with the FDA for Cardiovit At-10plus.
Device ID | K050686 |
510k Number | K050686 |
Device Name: | CARDIOVIT AT-10PLUS |
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 | 2005-03-16 |
Decision Date | 2005-05-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613365000054 | K050686 | 000 |