510(k) K850071

TECA MF-20 MICROVASCULAR DOPPLER by Teca, Inc. — Product Code IYN

K850071 is an FDA 510(k) premarket notification submitted by Teca, Inc. for the device "TECA MF-20 MICROVASCULAR DOPPLER". The FDA issued a decision of Substantially Equivalent on April 2, 1985. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Teca, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1985
Date Received
January 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type