510(k) K884477

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B by Shimadzu Precision Instruments, Inc. — Product Code KPR

K884477 is an FDA 510(k) premarket notification submitted by Shimadzu Precision Instruments, Inc. for the device "SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B". The FDA issued a decision of Substantially Equivalent on March 15, 1989. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Shimadzu Precision Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1989
Date Received
October 25, 1988
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