The following data is part of a premarket notification filed by Wearlinq, Inc. with the FDA for Ewave Monitor.
| Device ID | K214073 |
| 510k Number | K214073 |
| Device Name: | EWave Monitor |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | WearLinq, Inc. 1819 Polk St #148 San Francisco, CA 94109 |
| Contact | Konrad Morzkowski |
| Correspondent | Konrad Morzkowski WearLinq, Inc. 1819 Polk St #148 San Francisco, CA 94109 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-10-20 |