The following data is part of a premarket notification filed by Intel-ge Care Innovations Llc with the FDA for Intel-ge Care Innovations Quietcare.
| Device ID | K131585 |
| 510k Number | K131585 |
| Device Name: | INTEL-GE CARE INNOVATIONS QUIETCARE |
| Classification | Monitor, Bed Patient |
| Applicant | INTEL-GE CARE INNOVATIONS LLC 1721 DOUGLAS BLVD SUITE 100 Roseville, CA 95661 |
| Contact | Maureen Glynn |
| Correspondent | Maureen Glynn INTEL-GE CARE INNOVATIONS LLC 1721 DOUGLAS BLVD SUITE 100 Roseville, CA 95661 |
| Product Code | KMI |
| CFR Regulation Number | 880.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-31 |
| Decision Date | 2013-10-08 |
| Summary: | summary |