The following data is part of a premarket notification filed by Keithley Instruments, Inc. with the FDA for Tn-rd-50.
Device ID | K932598 |
510k Number | K932598 |
Device Name: | TN-RD-50 |
Classification | Accelerator, Linear, Medical |
Applicant | KEITHLEY INSTRUMENTS, INC. 2875 AURORA RD. Cleveland, OH 44139 |
Contact | Zisimos P Giatis |
Correspondent | Zisimos P Giatis 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 | 1993-05-28 |
Decision Date | 1994-06-03 |