The following data is part of a premarket notification filed by Caretaker Medical, Llc with the FDA for Caretaker Monitor App.
| Device ID | K213699 |
| 510k Number | K213699 |
| Device Name: | CareTaker Monitor App |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Caretaker Medical, LLC 941 Glenwood Station Ln, Suite 301 Charlottesville, VA 22901 |
| Contact | Jeff Pompeo |
| Correspondent | Jeff Pompeo Caretaker Medical, LLC 941 Glenwood Station Ln, Suite 301 Charlottesville, VA 22901 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-23 |
| Decision Date | 2022-03-30 |