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

TRAVELAIRE

K Number: K811404 · Decision Jun 9, 1981
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
61
Applicant Total
18
Review Days
22

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Basic Information

Device Name
TRAVELAIRE
K Number
K811404
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5640
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
B & F Medical Products, Inc.
Date Received
May 18, 1981
Decision Date
June 9, 1981
Product Code
CCQ
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
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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Other Clearances by B & F Medical Products, Inc.

K Number Device Name
K942645 B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG
K920573 CANNULA NASAL OXYGEN
K913501 TRACHEOSTOMY MASK
K861325 MAXI-USE O2 DEVICE
K861054 DISPOSABLE RESCUE BREATHING DEVICE
K853004 PORTABLE OXYGEN UNIT
K843691 PORTABLE OXYGEN UNIT
K823532 STOCK #64091-PEDIATRIC OXYGEN MASK
K802644 EMERG. OXYGEN KIT #65350 & #65399 CASE
K802646 HAND PERCUSSOR CUP #65210
Search all 18 clearances from B & F Medical Products, Inc. →