510(k) K012003

Device: DRG REACTION CHAMBER/SAFETY TIP
Applicant: DOCTOR'S RESEARCH GROUP, INC.
510(k) number: K012003
Product code: HEI
Decision: Substantially Equivalent (SESE)
Decision date: 2002-02-12
Date received: 2001-06-27
Regulation: 884.2660
Classification name: Monitor, Heart-valve Movement, Fetal, Ultrasonic
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: RICHARD DESLAURIERS
Address: 143 Wolcott Rd. Wolcott CT US 06716 06716

Source Documents#

Other 510(k) Records For Product Code HEI #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K920985	SNOWDEN-PENCER IRRIGATION PUMP	Snowden-Pencer	1992-06-09
K910982	INNERVISION IRRIGATION PUMP	M.D. Engineering, Inc.	1991-08-26

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases