The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zio Sr Ecg Monitoring Service.
| Device ID | K143513 |
| 510k Number | K143513 |
| Device Name: | ZIO SR ECG Monitoring Service |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | iRhythm Technologies, Inc. 650 Townsend Street, Ste 380 San Francisco, CA 94103 |
| Contact | Rich Laguna |
| Correspondent | Rich Laguna iRhythm Technologies, Inc. 650 Townsend Street, Ste 380 San Francisco, CA 94103 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-11 |
| Decision Date | 2015-06-19 |
| Summary: | summary |