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 |