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510(k) Premarket Notification Database

Device Classification Name:	PLETHYSMOGRAPH, IMPEDANCE
Regulation Number:	870.2770 [See Other Products with this regulation number]
510(k) Number:	K032491
Device Name:	ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
Applicant:	IMAGYN MEDICAL TECHNOLOGIES, INC. 1 PARK PLAZA, SUITE 1100 IRVINE, CA 92614
Contact:	JULIE POWELL
Product Code:	DSB [See Other Manufacturers that make this Product]
Date Received:	08-12-2003
Decision Date:	09-04-2003
Decision:	SU
Advisory Committee:	CV
Statement/Summary/Purged Status:	Summary
Type:	Special
Review by Third Party:	N
Expedited Review:	N

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