510(k) K941931

DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR by Victoreen, Inc. — Product Code KPR

K941931 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR". The FDA issued a decision of Substantially Equivalent on May 26, 1994. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Victoreen, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1994
Date Received
April 20, 1994
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