Product code HEI

Device name: Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Medical specialty: Obstetrics/Gynecology
Device class: 2
Regulation number: 884.2660
Review panel: OB
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K012003	DRG REACTION CHAMBER/SAFETY TIP	Doctor'S Research Group, Inc.	2002-02-12
K920985	SNOWDEN-PENCER IRRIGATION PUMP	Snowden-Pencer	1992-06-09
K910982	INNERVISION IRRIGATION PUMP	M.D. Engineering, Inc.	1991-08-26