The following data is part of a premarket notification filed by Caretaker Medical, Llc with the FDA for Caretaker Continuous Non-lnvasive Blood Pressure Monitor, Caretaker Wireless Vital Signs Monitor, Caretaker Physiological Monitor.
| Device ID | K163255 |
| 510k Number | K163255 |
| Device Name: | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Caretaker Medical, LLC 3042 Berkmar Drive, Suite A Charlottesville, VA 22901 |
| Contact | Jeff Pompeo |
| Correspondent | Jeff Pompeo Caretaker Medical, LLC 3042 Berkmar Drive, Suite A 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 | 2016-11-21 |
| Decision Date | 2017-04-21 |
| Summary: | summary |