The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Blood Oxygenation Level Dependent (bold) Option.
| Device ID | K010691 |
| 510k Number | K010691 |
| Device Name: | BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Duane Praschan |
| Correspondent | Duane Praschan 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 | 2001-03-08 |
| Decision Date | 2001-05-08 |