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 |