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510(k) Premarket Notification Database

Device Classification Name:	MONITOR, BLOOD PRESSURE, INDIRECT, SEMI-AUTOMATIC
Regulation Number:	870.1130 [See Other Products with this regulation number]
510(k) Number:	K031964
Device Name:	BPCARD
Applicant:	QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH PLYMOUTH, MN 55447
Contact:	MARY KAY JENSEN
Product Code:	DXN [See Other Manufacturers that make this Product]
Date Received:	06-25-2003
Decision Date:	09-05-2003
Decision:	SE
Advisory Committee:	CV
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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