510(k) K900882

MULTI DOPPLEX, MD-1 by Huntleigh Technology, Inc. — Product Code JAF

K900882 is an FDA 510(k) premarket notification submitted by Huntleigh Technology, Inc. for the device "MULTI DOPPLEX, MD-1". The FDA issued a decision of Substantially Equivalent on August 22, 1990. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. Huntleigh Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
February 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type