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510(k) K960916

Device
SAMS 8000 CARDIOPLEGIA MONITOR
Applicant
3M HEALTH CARE, SARNS
510(k) number
K960916
Product code
DSJ  
Decision
Substantially Equivalent (SESE)
Decision date
1996-06-04
Date received
1996-03-06
Regulation
870.1100
Classification name
Alarm, Blood-pressure
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHERYL ROSENBERG
Address
6200 Jackson Rd. Ann Arbor MI US 48103 48103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH2019-10-27
K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017-03-31
K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems2015-09-29
K133961SURESIGNS VS3, SURESIGNS VS4Philips Medical Systems2014-06-26
K910262KELLER VITAL SIGNS MONITOR - KMS-890Keller Medical Specialties Products, Inc.1991-04-01

Legacy Summary#

summary

FDA Review#

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