The following data is part of a premarket notification filed by Tingle X-ray Products, Inc. with the FDA for 525 Sfq X-ray Control W/high Voltage Generator.
Device ID | K926554 |
510k Number | K926554 |
Device Name: | 525 SFQ X-RAY CONTROL W/HIGH VOLTAGE GENERATOR |
Classification | System, X-ray, Stationary |
Applicant | TINGLE X-RAY PRODUCTS, INC. 10629 TXR RD. Vance, AL 35490 |
Contact | Jerry M Tingle |
Correspondent | Jerry M Tingle TINGLE X-RAY PRODUCTS, INC. 10629 TXR RD. Vance, AL 35490 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-31 |
Decision Date | 1993-05-17 |