The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Ecard And Ccard.
| Device ID | K081471 |
| 510k Number | K081471 |
| Device Name: | ECARD AND CCARD |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | IRHYTHM TECHNOLOGIES, INC. 650 TOWNSEND STREET SUITE 380 San Francisco, CA 94103 |
| Contact | William H Righter |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-05-27 |
| Decision Date | 2008-06-24 |