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

CANNULA BAND

K Number: K860261 · Decision Feb 18, 1986
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
41
Applicant Total
5
Review Days
25

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Basic Information

Device Name
CANNULA BAND
K Number
K860261
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5340
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
T. G. & E. Medical
Date Received
January 24, 1986
Decision Date
February 18, 1986
Product Code
CAT
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
CAT Cannula, Nasal, Oxygen

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K820941 THERMA-SCAN
K813199 SKIN TEMPERATURE SENSING VINYL STRIP