The following data is part of a premarket notification filed by Cardiac Designs, Llc with the FDA for Ecg Check.
| Device ID | K122184 |
| 510k Number | K122184 |
| Device Name: | ECG CHECK |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARDIAC DESIGNS, LLC 3293 NIBLICK DRIVE Park City, UT 84098 |
| Contact | Karim Marrouche |
| Correspondent | Karim Marrouche CARDIAC DESIGNS, LLC 3293 NIBLICK DRIVE Park City, UT 84098 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-23 |
| Decision Date | 2013-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B287ECG01U0 | K122184 | 000 |