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

TRAVONEB MODEL # TONE 1

K Number: K854747 · Decision Feb 24, 1986
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
4
Review Days
90

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Basic Information

Device Name
TRAVONEB MODEL # TONE 1
K Number
K854747
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.6250
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Travomed, Inc.
Date Received
November 26, 1985
Decision Date
February 24, 1986
Product Code
BTI
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
BTI Compressor, Air, Portable

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Other Clearances by Travomed, Inc.

K Number Device Name
K864127 MECHANICAL OXYGEN REGULATOR
K854748 TRAVELPAK MODEL DC-202
K854509 TRAVELPAK MODEL AC-102