The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Neuromag-122.
| Device ID | K962764 |
| 510k Number | K962764 |
| Device Name: | NEUROMAG-122 |
| Classification | Magnetoencephalograph |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Contact | Elaine K Keeler |
| Correspondent | Elaine K Keeler PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Product Code | OLY |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-16 |
| Decision Date | 1996-10-31 |
| Summary: | summary |