FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

POLARISED LIGHT GRONIOMETER

K Number: K810640 · Decision Apr 17, 1981
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
9
Review Days
38

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Basic Information

Device Name
POLARISED LIGHT GRONIOMETER
K Number
K810640
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
888.1500
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Cairco , Ltd.
Date Received
March 10, 1981
Decision Date
April 17, 1981
Product Code
KQX
Advisory Committee
Orthopedic
Review Advisory Committee
NE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KQX Goniometer, Ac-Powered

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K812958 EAST-FREEMAN VENTILATOR MARK 2
K812955 EAST WATER UNIT MARK 3
K812953 RADCLIFFE VENTILATOR MARK 5
K812960 EAST VENTILARM PRESSURE MONITOR ALARM S.