The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Bennett Bca-6 &bca-9 Mobile C-arm Unit/radio/flour.
Device ID | K883092 |
510k Number | K883092 |
Device Name: | BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR |
Classification | System, X-ray, Mobile |
Applicant | BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Contact | Howard Rosenberg |
Correspondent | Howard Rosenberg BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-22 |
Decision Date | 1988-10-13 |