The following data is part of a premarket notification filed by Keithley Instruments, Inc. with the FDA for Model 35300 Tracker(tm) Therapy Beam Evaluator.
| Device ID | K874893 |
| 510k Number | K874893 |
| Device Name: | MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR |
| Classification | Accelerator, Linear, Medical |
| Applicant | KEITHLEY INSTRUMENTS, INC. 2875 AURORA RD. Cleveland, OH 44139 |
| Contact | Mitchell Bednarek |
| Correspondent | Mitchell Bednarek KEITHLEY INSTRUMENTS, INC. 2875 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 | 1987-12-01 |
| Decision Date | 1988-02-17 |