The following data is part of a premarket notification filed by Tingle X-ray Products, Inc. with the FDA for Txr 325 X-ray Control With High Voltage Generator.
Device ID | K860203 |
510k Number | K860203 |
Device Name: | TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR |
Classification | Generator, High-voltage, X-ray, Diagnostic |
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 | IZO |
CFR Regulation Number | 892.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-22 |
Decision Date | 1986-01-30 |