The following data is part of a premarket notification filed by Keithley Instruments, Inc. with the FDA for Advanced Therapy Dosimeter.
| Device ID | K942083 |
| 510k Number | K942083 |
| Device Name: | ADVANCED THERAPY DOSIMETER |
| Classification | Accelerator, Linear, Medical |
| Applicant | KEITHLEY INSTRUMENTS, INC. 28775 AURORA RD. Cleveland, OH 44139 |
| Contact | Zisimos P Giatis |
| Correspondent | Zisimos P Giatis KEITHLEY INSTRUMENTS, INC. 28775 AURORA RD. Cleveland, OH 44139 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-29 |
| Decision Date | 1994-09-02 |