510(k) K935649

WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY by Bennett X-Ray Corp. — Product Code KPR

K935649 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY". The FDA issued a decision of Substantially Equivalent on February 9, 1994. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1994
Date Received
November 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type