510(k) K913243

BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE by Bennett X-Ray Corp. — Product Code IXG

K913243 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE". The FDA issued a decision of Substantially Equivalent on September 19, 1991. The device falls under product code IXG (Phantom, Anthropomorphic, Radiographic), a Class I device regulated under 21 CFR 892.1950. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1991
Date Received
July 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phantom, Anthropomorphic, Radiographic
Device Class
Class I
Regulation Number
892.1950
Review Panel
RA
Submission Type