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510(k) K050313

Device
BIS SRS (SEMI-RESUABLE SENSOR)
Applicant
ASPECT MEDICAL SYSTEMS, INC.
510(k) number
K050313
Product code
GWY  
Decision
Substantially Equivalent (SESE)
Decision date
2005-02-24
Date received
2005-02-09
Regulation
882.1750
Classification name
Pinwheel
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
CHRISTINE VOZELLA
Address
141 Needham St. Newton MA US 02464 02464

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GWY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K942926NEURO-AIDEBurke Neutech, Inc.1994-08-03
K871167SENSITESTERDexin Pty. , Ltd.1987-04-01
K8517491-380 PINWHEEL (WARTENBERG)Artiberia1985-06-13
K780422PINWHEELProjects IN Health1978-04-04

Legacy Summary#

summary

FDA Review#

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