The following data is part of a premarket notification filed by Aframe Digital, Inc. with the FDA for Mobilecare Monitor.
| Device ID | K122333 |
| 510k Number | K122333 |
| Device Name: | MOBILECARE MONITOR |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | AFRAME DIGITAL, INC. 1889 PRESTON WHITE DR STE 101 Reston, VA 20191 |
| Contact | Jill Thorpe |
| Correspondent | Jill Thorpe AFRAME DIGITAL, INC. 1889 PRESTON WHITE DR STE 101 Reston, VA 20191 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-02 |
| Decision Date | 2012-11-19 |
| Summary: | summary |