The following data is part of a premarket notification filed by Caretaker Medical, Llc with the FDA for Caretaker Continuous Non-invasive Blood Pressure Monitor, Caretaker Wireless Vital Signs Monitor.
| Device ID | K151499 |
| 510k Number | K151499 |
| Device Name: | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CARETAKER MEDICAL, LLC 3042 BERKMAR DRIVE SUITE A Charlottesville, VA 22901 -1455 |
| Contact | Jeff Pompeo |
| Correspondent | Jeff Pompeo CARETAKER MEDICAL, LLC 3042 BERKMAR DRIVE SUITE A Charlottesville, VA 22901 -1455 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-04 |
| Decision Date | 2016-03-18 |
| Summary: | summary |