The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Gemini Condor.
| Device ID | K081135 |
| 510k Number | K081135 |
| Device Name: | GEMINI CONDOR |
| Classification | System, Tomography, Computed, Emission |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Melinda Novatny |
| Correspondent | Morten Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-21 |
| Decision Date | 2008-04-29 |
| Summary: | summary |