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

NEUMOVENT 980

K Number: K821792 · Decision Aug 2, 1982
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
1
Review Days
46

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Basic Information

Device Name
NEUMOVENT 980
K Number
K821792
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5895
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Ultramar Marketing Corp.
Date Received
June 17, 1982
Decision Date
August 2, 1982
Product Code
CBK
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
CBK Ventilator, Continuous, Facility Use

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