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

NO. 1552, VALVED VENTI-COMP

K Number: K870895 · Decision May 4, 1987
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
33
Review Days
60

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Basic Information

Device Name
NO. 1552, VALVED VENTI-COMP
K Number
K870895
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5870
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Hudson Oxygen Therapy Sales Co.
Date Received
March 5, 1987
Decision Date
May 4, 1987
Product Code
CBP
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
CBP Valve, Non-Rebreathing

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K895589 MANUAL RESUSCITATOR
K896136 INFANT C.P.A.P. MONITOR
K895231 CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
K895747 VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
K890035 BACTERIA FILTER
K871157 C.P.A.P. NASAL CANNULA
K870138 1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE
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