FDA 510(k) Application Details - K012003

Device Classification Name	Monitor, Heart-Valve Movement, Fetal, Ultrasonic   More FDA Info for this Device
510(K) Number	K012003
Device Name	Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Applicant	DOCTOR'S RESEARCH GROUP, INC. 143 WOLCOTT RD. WOLCOTT, CT 06716 US Other 510(k) Applications for this Company
Contact	RICHARD DESLAURIERS Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	HEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2001
Decision Date	02/12/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review