The following data is part of a premarket notification filed by Northwest Medical Physics Center with the FDA for Head Immobilization Apparatus.
| Device ID | K941118 |
| 510k Number | K941118 |
| Device Name: | HEAD IMMOBILIZATION APPARATUS |
| Classification | Accelerator, Linear, Medical |
| Applicant | NORTHWEST MEDICAL PHYSICS CENTER 21031 67TH AVE. W. Lynnwood, WA 98036 |
| Contact | Andrew Jones |
| Correspondent | Andrew Jones NORTHWEST MEDICAL PHYSICS CENTER 21031 67TH AVE. W. Lynnwood, WA 98036 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-07 |
| Decision Date | 1995-08-25 |