The following data is part of a premarket notification filed by Intel-ge Care Innovations Llc with the FDA for Modification To Intel-ge Care Iinovations Guide.
| Device ID | K130290 |
| 510k Number | K130290 |
| Device Name: | MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | INTEL-GE CARE INNOVATIONS LLC 3721 DOUGLAS BOULEVARD SUITE 100 Roseville, CA 95661 |
| Contact | Maureen Glynn |
| Correspondent | Maureen Glynn INTEL-GE CARE INNOVATIONS LLC 3721 DOUGLAS BOULEVARD SUITE 100 Roseville, CA 95661 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-06 |
| Decision Date | 2013-06-04 |
| Summary: | summary |