The following data is part of a premarket notification filed by Schiller Ag with the FDA for Cardiovit Ft-1.
Device ID | K170182 |
510k Number | K170182 |
Device Name: | CARDIOVIT FT-1 |
Classification | Electrocardiograph |
Applicant | SCHILLER AG ALTGASSE 68 Baar, CH Ch-6371 |
Contact | Zhenrong Yu |
Correspondent | Jim Chickering ZOE MEDICAL, INC 460 BOSTON STREET Topsfield, MA 01983 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-23 |
Decision Date | 2017-07-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613365002003 | K170182 | 000 |
07613365002027 | K170182 | 000 |
07613365003789 | K170182 | 000 |
07613365003642 | K170182 | 000 |
07613365002867 | K170182 | 000 |
07613365000184 | K170182 | 000 |
07613365001969 | K170182 | 000 |
07613365001976 | K170182 | 000 |
07613365001983 | K170182 | 000 |
07613365001990 | K170182 | 000 |
07613365002225 | K170182 | 000 |