The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Whis-rad Tubstand Structure/mobile Patient Trolley.
Device ID | K935649 |
510k Number | K935649 |
Device Name: | WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY |
Classification | System, X-ray, Stationary |
Applicant | BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Contact | Robert P Coe |
Correspondent | Robert P Coe BENNETT X-RAY CORP. 54 RAILROAD AVE. Copiague, NY 11726 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-23 |
Decision Date | 1994-02-09 |