The following data is part of a premarket notification filed by Schiller Ag with the FDA for Diagnostic Station Ds20.
| Device ID | K152043 |
| 510k Number | K152043 |
| Device Name: | Diagnostic Station DS20 |
| Classification | Electrocardiograph |
| Applicant | SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341 |
| 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 | 2015-07-23 |
| Decision Date | 2016-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613365001808 | K152043 | 000 |
| 07613365000474 | K152043 | 000 |
| 07613365000481 | K152043 | 000 |
| 07613365000498 | K152043 | 000 |
| 07613365001754 | K152043 | 000 |
| 07613365001761 | K152043 | 000 |
| 07613365001778 | K152043 | 000 |
| 07613365001785 | K152043 | 000 |
| 07613365001792 | K152043 | 000 |
| 07613365000467 | K152043 | 000 |