The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Brain Perfusion Option.
| Device ID | K033677 |
| 510k Number | K033677 |
| Device Name: | BRAIN PERFUSION OPTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER ROAD Highland Hts., OH 44143 |
| Contact | Robert L Turocy |
| Correspondent | Robert L Turocy PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER ROAD Highland Hts., OH 44143 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2004-02-20 |
| Summary: | summary |