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

MODEL MEDILOG RAPIDE

K Number: K923737 · Decision Jan 5, 1994
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
48
Review Days
527

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Basic Information

Device Name
MODEL MEDILOG RAPIDE
K Number
K923737
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.2375
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Oxford Medilog, Inc.
Date Received
July 27, 1992
Decision Date
January 5, 1994
Product Code
BZQ
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

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

Product Code Device Name
BZQ Monitor, Breathing Frequency

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K902690 SONICAID MODEL MERIDIAN 800
K895909 SONICAID MODEL VASOFLO 4
K896535 MEDILOG OPTIMA
K891383 MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM
K890330 MEDILOG 6000-FD REPORT GENERATOR
K890338 MEDILOG EDITOR
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