510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K990569Substantially Equivalent

Baby Dopplex 4000, Model Bd 4000

Huntleigh Healthcare Ltd., Manalapan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990569 is the FDA 510(k) clearance record for BABY DOPPLEX 4000, MODEL BD 4000, a class II device, cleared for Huntleigh Healthcare, Inc. on under FDA product code HGM (System, Monitoring, Perinatal). FDA records list 27 510(k) clearances for Huntleigh Healthcare, Inc., from to . As of , FDA records show no recalls naming K990569.

Clearance record

Decision date
Received
(335 days to decision)
Product code
HGM System, Monitoring, Perinatal
Regulation
21 CFR 884.2740
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Huntleigh Healthcare, Inc. 227 Rt. 33 E., Manalapan NJ
510(k) summary
Summary
Third party review
No

Clearances, product code HGM

Trailing 12 months
2 clearances under product code HGM in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HGM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260