510(k) K940701

BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH by Bennett X-Ray Corp. — Product Code IZH

K940701 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH". The FDA issued a decision of Substantially Equivalent on April 28, 1994. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1994
Date Received
February 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type