The following data is part of a premarket notification filed by Intel Corp. with the FDA for Modification To Intel Health Guide, Model Phs6000.
| Device ID | K083115 |
| 510k Number | K083115 |
| Device Name: | MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | INTEL CORP. 1900 PRAIRIE CITY RD., FM7-197 Folsom, CA 95630 |
| Contact | Tae-woong Koo |
| Correspondent | Tae-woong Koo INTEL CORP. 1900 PRAIRIE CITY RD., FM7-197 Folsom, CA 95630 |
| Product Code | DRG |
| Subsequent Product Code | CGA |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-21 |
| Decision Date | 2008-11-26 |
| Summary: | summary |