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

CONCENTRACTORS

K Number: K842114 · Decision Jun 15, 1984
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
1
Review Days
73

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Basic Information

Device Name
CONCENTRACTORS
K Number
K842114
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5440
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Amox Corp.
Date Received
April 3, 1984
Decision Date
June 15, 1984
Product Code
CAW
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
CAW Generator, Oxygen, Portable

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