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

RICO RESPIRATION MONITOR

K Number: K840975 · Decision Mar 30, 1984
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
1
Review Days
24

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Basic Information

Device Name
RICO RESPIRATION MONITOR
K Number
K840975
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1850
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
J.M. Laboratories, Inc.
Date Received
March 6, 1984
Decision Date
March 30, 1984
Product Code
BZK
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
BZK Spirometer, Monitoring (W/Wo Alarm)

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