The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Gemini Gxl.
| Device ID | K042935 |
| 510k Number | K042935 |
| Device Name: | GEMINI GXL |
| Classification | System, Tomography, Computed, Emission |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Rae Ann Farrow |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-25 |
| Decision Date | 2004-11-09 |
| Summary: | summary |