The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Pcr Eleva 1.2.
| Device ID | K093355 |
| 510k Number | K093355 |
| Device Name: | PCR ELEVA 1.2 |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98041 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS MEDICAL SYSTEMS, INC. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98041 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-27 |
| Decision Date | 2010-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838074569 | K093355 | 000 |
| 00884838004047 | K093355 | 000 |