The following data is part of a premarket notification filed by Gammex, Inc. with the FDA for Pid-1 Precision Intelligent Dosimeter.
| Device ID | K954564 |
| 510k Number | K954564 |
| Device Name: | PID-1 PRECISION INTELLIGENT DOSIMETER |
| Classification | Accelerator, Linear, Medical |
| Applicant | GAMMEX, INC. 2500 WEST BELTLINE HWY. P.O. BOX 620327 Middleton, WI 53562 -0327 |
| Contact | Thomas A Demke |
| Correspondent | Thomas A Demke GAMMEX, INC. 2500 WEST BELTLINE HWY. P.O. BOX 620327 Middleton, WI 53562 -0327 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1996-04-22 |
| Summary: | summary |