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510(k) K871167

Device
SENSITESTER
Applicant
DEXIN PTY. LTD.
510(k) number
K871167
Product code
GWY  
Decision
Substantially Equivalent (SESE)
Decision date
1987-04-01
Date received
1987-03-24
Regulation
882.1750
Classification name
Pinwheel
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DR. S BAJADA
Address
221 High St. Fremantle, 6160 Western Australia AU

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GWY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050313BIS SRS (SEMI-RESUABLE SENSOR)Aspect Medical Systems, Inc.2005-02-24
K942926NEURO-AIDEBurke Neutech, Inc.1994-08-03
K8517491-380 PINWHEEL (WARTENBERG)Artiberia1985-06-13
K780422PINWHEELProjects IN Health1978-04-04

Legacy Summary#

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FDA Review#

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