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510(k) K926099

Device
DATASCOPE 6000 MONITOR
Applicant
DATASCOPE CORP.
510(k) number
K926099
Product code
MLC  
Decision
Substantially Equivalent (SESE)
Decision date
1993-08-06
Date received
1992-12-03
Regulation
870.2340
Classification name
Monitor, St Segment
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL BARILE
Address
580 Winters Ave. P.O. Box 5 Paramus NJ US 07653 07653

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MLC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K993826NARKOMED 6000Draeger Medical, Inc.2000-03-23

Legacy Summary#

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FDA Review#

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