The following data is part of a premarket notification filed by Caretaker Medical, Llc with the FDA for Caretaker Remote Display App And Caretaker Software Library.
| Device ID | K181196 |
| 510k Number | K181196 |
| Device Name: | Caretaker Remote Display App And Caretaker Software Library |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| 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 | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-10-03 |
| Summary: | summary |