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510(k) K163649

Device
SureSigns VS3; SureSigns VS4
Applicant
Philips Medical Systems
510(k) number
K163649
Product code
DSJ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-03-31
Date received
2016-12-23
Regulation
870.1100
Classification name
Alarm, Blood-pressure
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Greg Li
Address
3000 Minuteman Rd. Andover MA US 01810 01810

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
K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems2015-09-29
K133961SURESIGNS VS3, SURESIGNS VS4Philips Medical Systems2014-06-26
K960916SAMS 8000 CARDIOPLEGIA MONITOR3M Health Care, Sarns1996-06-04
K910262KELLER VITAL SIGNS MONITOR - KMS-890Keller Medical Specialties Products, Inc.1991-04-01

Legacy Summary#

summary

FDA Review#

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