The following data is part of a premarket notification filed by Cardiac Designs, Inc. with the FDA for Ecg Check - Universal, Ecg Check - Universal Plus.
| Device ID | K170506 |
| 510k Number | K170506 |
| Device Name: | ECG Check - Universal, ECG Check - Universal Plus |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | Cardiac Designs, Inc. 25510 Interstate 45 N Suite 202 Spring, TX 77386 |
| Contact | James Tassone |
| Correspondent | Cynthia J. Pillar CJP Consulting, Inc. 5831 N Kostner Ave Chigaco, IL 60646 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-21 |
| Decision Date | 2017-10-02 |
| Summary: | summary |