510(k) K842777

AUTOFOCUS DUAL ELEMENT PROBE by Technicare Corp. — Product Code IYO

K842777 is an FDA 510(k) premarket notification submitted by Technicare Corp. for the device "AUTOFOCUS DUAL ELEMENT PROBE". The FDA issued a decision of Substantially Equivalent on November 29, 1984. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Technicare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1984
Date Received
July 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type