510(k) K900618

HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 by Huntleigh Technology, Inc. — Product Code KNG

K900618 is an FDA 510(k) premarket notification submitted by Huntleigh Technology, Inc. for the device "HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140". The FDA issued a decision of Substantially Equivalent on April 25, 1990. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Huntleigh Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1990
Date Received
February 8, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type