The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Quantitative Flow.
| Device ID | K992225 |
| 510k Number | K992225 |
| Device Name: | QUANTITATIVE FLOW |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Elaine K Keeler |
| Correspondent | Elaine K Keeler PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-02 |
| Decision Date | 1999-09-07 |
| Summary: | summary |