The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Hfq Series Controls And Generators.
Device ID | K905799 |
510k Number | K905799 |
Device Name: | HFQ SERIES CONTROLS AND GENERATORS |
Classification | Generator, High-voltage, X-ray, Diagnostic |
Applicant | BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Contact | Schneider |
Correspondent | Schneider BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Product Code | IZO |
CFR Regulation Number | 892.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-30 |
Decision Date | 1991-02-26 |