The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Trauma View Rad Syst Model #b-trv/stret Mobil Tabl.
Device ID | K912696 |
510k Number | K912696 |
Device Name: | TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL |
Classification | Tube Mount, 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 | IYB |
CFR Regulation Number | 892.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-18 |
Decision Date | 1991-09-16 |