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

VENTILATOR ADAPTOR, #751

K Number: K770587 · Decision Apr 5, 1977
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
19
Review Days
8

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Basic Information

Device Name
VENTILATOR ADAPTOR, #751
K Number
K770587
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5810
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Surgicot, Inc.
Date Received
March 28, 1977
Decision Date
April 5, 1977
Product Code
BZA
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
BZA Connector, Airway (Extension)

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K863122 ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.
K855101 ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR
K854631 ASSERT EO BIOLOGICAL TEST PACK
K854902 SURGICOT STEAM TEST PACK
K840541 NEURO SPONGE
K840471 EYE SPEAR
K840470 SURGISCRIBE MARKING PEN
K830739 PRO-GUARD
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