FDA.reportPublic FDA data

510(k) K770782

Device
FIBERSCOPIC SCOPE RECORDER SYSTEM
Applicant
Elmed, Inc.
510(k) number
K770782
Product code
GWK
Decision
Substantially Equivalent (SESE)
Decision date
1977-05-06
Date received
1977-05-02
Regulation
882.1845
Classification name
Conditioner, Signal, Physiological
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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