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510(k) K913604

Device
SOMATOSENSORY STIMULUS SYSTEM
Applicant
BIOMAGNETIC TECHNOLOGIES, INC.
510(k) number
K913604
Product code
GZP  
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-09
Date received
1991-08-14
Regulation
882.1880
Classification name
Stimulator, Mechanical, Evoked Response
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GERALD S PALECKI
Address
9727 Pacific Heights Blvd. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GZP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191700EyeStatBlinktbi, Inc.2019-12-09

Legacy Summary#

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FDA Review#

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