510(k) K930230

RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER by American Medical Sales, Inc. — Product Code IXY

K930230 is an FDA 510(k) premarket notification submitted by American Medical Sales, Inc. for the device "RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER". The FDA issued a decision of Substantially Equivalent on April 27, 1993. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. American Medical Sales, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1993
Date Received
January 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Radiographic Cassette, Wall-Mounted
Device Class
Class I
Regulation Number
892.1880
Review Panel
RA
Submission Type