The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Voyager 6.0 Software Option.
| Device ID | K000310 |
| 510k Number | K000310 |
| Device Name: | VOYAGER 6.0 SOFTWARE OPTION |
| Classification | Neurological Stereotaxic Instrument |
| 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 | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-01 |
| Decision Date | 2000-02-15 |