FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

LA MONT VIDEO PATIENT MONITORING SYSTEM

K Number: K921485 · Decision Oct 22, 1992
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
8
Review Days
206

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Basic Information

Device Name
LA MONT VIDEO PATIENT MONITORING SYSTEM
K Number
K921485
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.1400
Medical Specialty
Neurology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Medical Systems Corp.
Date Received
March 30, 1992
Decision Date
October 22, 1992
Product Code
GWQ
Advisory Committee
Neurology
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
GWQ Full-Montage Standard Electroencephalograph

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K903501 RADIANT TEMPERATUR INDICATOR MODEL 25E
K902192 MODEL MSC SA02-5000 PULSE OXIMETER
K902608 CARDIOMATIC MODEL MSC-1001
K770878 SIGNAL PROCESSOR/AVERAGER MODEL 7S11