The following data is part of a premarket notification filed by Watermark Medical with the FDA for Connected Care Mobile Application.
| Device ID | K120325 |
| 510k Number | K120325 |
| Device Name: | CONNECTED CARE MOBILE APPLICATION |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | WATERMARK MEDICAL 12715 FALCON DRIVE Brookfield, WI 53005 |
| Contact | Michael J Leigh |
| Correspondent | Michael J Leigh WATERMARK MEDICAL 12715 FALCON DRIVE Brookfield, WI 53005 |
| Product Code | DRG |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FRI |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-02 |
| Decision Date | 2012-07-18 |
| Summary: | summary |