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

OXYGEN-RICH

K Number: K760704 · Decision Oct 5, 1976
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
2
Review Days
15

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Basic Information

Device Name
OXYGEN-RICH
K Number
K760704
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5440
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Xorbox
Date Received
September 20, 1976
Decision Date
October 5, 1976
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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K Number Device Name
K781074 OXYGEN RICH AIR SUPPLY UNIT-MODEL 390