510(k) K922079

ROTOLUX, SELECTOLUX, SHUTTERVUE by American Medical Sales, Inc. — Product Code IXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1992
Date Received
May 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Radiographic-Film
Device Class
Class I
Regulation Number
892.1890
Review Panel
RA
Submission Type