The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Neuromag Vectorview.
| Device ID | K984401 |
| 510k Number | K984401 |
| Device Name: | NEUROMAG VECTORVIEW |
| Classification | Source Localization Software For Electroencephalograph Or Magnetoencephalograph |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights, OH 44143 |
| Contact | Elaine K Keeler |
| Correspondent | Elaine K Keeler PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights, OH 44143 |
| Product Code | OLX |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OLY |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-09 |
| Decision Date | 1998-12-30 |
| Summary: | summary |