510(k) K923141

PHILIPS PRE-FILTER OPTION by Philips Medical Systems, Inc. — Product Code ITY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1993
Date Received
June 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Tube Housing, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1760
Review Panel
RA
Submission Type