Home / 510(k) Clearances / K904901

510(k) K904901

L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC by Parexel Intl. Corp. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1991
Date Received
October 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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