510(k) K915696

INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE by Interspec, Inc. — Product Code ITX

K915696 is an FDA 510(k) premarket notification submitted by Interspec, Inc. for the device "INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE". The FDA issued a decision of Substantially Equivalent on November 24, 1992. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Interspec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1992
Date Received
December 23, 1991
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