The following data is part of a premarket notification filed by Vocare, Inc with the FDA for Vocare Myhealth Tablet.
| Device ID | K111922 |
| 510k Number | K111922 |
| Device Name: | VOCARE MYHEALTH TABLET |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | VOCARE, INC 5225 EXPLORATION DRIVE Indianapolis, IN 46241 |
| Contact | Steve Peabody |
| Correspondent | Steve Peabody VOCARE, INC 5225 EXPLORATION DRIVE Indianapolis, IN 46241 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-06 |
| Decision Date | 2011-12-02 |
| Summary: | summary |