FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

UNIVERSAL EXAMINATION TABLE

K Number: K842108 · Decision Jul 17, 1984
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
25
Applicant Total
10
Review Days
49

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Basic Information

Device Name
UNIVERSAL EXAMINATION TABLE
K Number
K842108
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.1540
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
Engineering Dynamics Corp.
Date Received
May 29, 1984
Decision Date
July 17, 1984
Product Code
GZO
Advisory Committee
Neurology
Review Advisory Committee
RA
Third Party
N

Classifications

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

Product Code Device Name
GZO Device, Galvanic Skin Response Measurement

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K834098 STATIONARY EXERCISE BICYCLE
K828313 DIGITAL RADIOGRAPHY EXAMINATION TABLE
K802254 GENERAL ULTRASOUND EXAM. TABLE
K790545 STRESS TESTING SYSTEM, LATERAL TILTING
K790544 STRESS TESTING SYSTEM, MULTI-POSITION
K790466 U-MAT
K790499 MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER