The following data is part of a premarket notification filed by X-ray Systems with the FDA for Head Holding Device/sleep Apnea.
| Device ID | K884493 |
| 510k Number | K884493 |
| Device Name: | HEAD HOLDING DEVICE/SLEEP APNEA |
| Classification | Holder, Head, Radiographic |
| Applicant | X-RAY SYSTEMS 33061 GROESBECK HWY. Fraser, MI 48026 -1514 |
| Contact | Richard C Drumb |
| Correspondent | Richard C Drumb X-RAY SYSTEMS 33061 GROESBECK HWY. Fraser, MI 48026 -1514 |
| Product Code | IWY |
| CFR Regulation Number | 892.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-26 |
| Decision Date | 1989-01-12 |