The following data is part of a premarket notification filed by Cardiologs Technologies with the FDA for Cardiologs Ecg Analysis Platform.
Device ID | K170568 |
510k Number | K170568 |
Device Name: | CardioLogs ECG Analysis Platform |
Classification | Electrocardiograph |
Applicant | Cardiologs Technologies 15 Rue I'Ecole De Medecine Paris, FR 75006 |
Contact | Quentin De Snoeck |
Correspondent | Michael A. Daniel Daniel & Daniel Consulting, LLC 34 Jones Lane Gardnerville, NV 89460 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-27 |
Decision Date | 2017-06-26 |
Summary: | summary |