The following data is part of a premarket notification filed by Intel Corporation Digital Health Group with the FDA for Intel Health Guide.
| Device ID | K103276 |
| 510k Number | K103276 |
| Device Name: | INTEL HEALTH GUIDE |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | INTEL CORPORATION DIGITAL HEALTH GROUP 1900 PRAIRIE CITY ROAD FM7-197 Folsom, CA 95630 |
| Contact | Maureen Gylnn |
| Correspondent | Maureen Gylnn INTEL CORPORATION DIGITAL HEALTH GROUP 1900 PRAIRIE CITY ROAD FM7-197 Folsom, CA 95630 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-05 |
| Decision Date | 2011-02-08 |
| Summary: | summary |