The following data is part of a premarket notification filed by Watermark Medical Inc with the FDA for Connected Care Clinical Application.
| Device ID | K120320 |
| 510k Number | K120320 |
| Device Name: | CONNECTED CARE CLINICAL APPLICATION |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | WATERMARK MEDICAL INC 1117 Perimeter Ctr W Suite W514 Atlanta, GA 30338 |
| Contact | Michael J Leigh |
| Correspondent | Michael J Leigh WATERMARK MEDICAL INC 1117 Perimeter Ctr W Suite W514 Atlanta, GA 30338 |
| Product Code | DXN |
| Subsequent Product Code | DQA |
| Subsequent Product Code | FRI |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-02 |
| Decision Date | 2012-08-14 |
| Summary: | summary |