FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

AIRWAY, DUAL CHANNEL

K Number: K760488 · Decision Sep 3, 1976
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
33
Review Days
14

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Basic Information

Device Name
AIRWAY, DUAL CHANNEL
K Number
K760488
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5110
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Hudson Oxygen Therapy Sales Co.
Date Received
August 20, 1976
Decision Date
September 3, 1976
Product Code
CAE
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
CAE Airway, Oropharyngeal, Anesthesiology

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Other Clearances by Hudson Oxygen Therapy Sales Co.

K Number Device Name
K902062 PEEP VALVE
K900783 MDI ADAPTOR
K900470 IN-THE NEBULIZER
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
K870895 NO. 1552, VALVED VENTI-COMP
K871157 C.P.A.P. NASAL CANNULA
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