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 |