The following data is part of a premarket notification filed by Philips Medical Systems Gmbh, Dmc with the FDA for Philips Essenta Dr.
| Device ID | K070528 |
| 510k Number | K070528 |
| Device Name: | PHILIPS ESSENTA DR |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | PHILIPS MEDICAL SYSTEMS GMBH, DMC 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98041 -3003 |
| Contact | Lynn Harmer |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-02-23 |
| Decision Date | 2007-03-09 |
| Summary: | summary |