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

SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE

K Number: K770218 · Decision Feb 9, 1977
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
127
Applicant Total
174
Review Days
7

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Basic Information

Device Name
SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE
K Number
K770218
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5800
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Shiley, Inc.
Date Received
February 2, 1977
Decision Date
February 9, 1977
Product Code
BTO
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
BTO Tube, Tracheostomy (W/Wo Connector)

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K911876 SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K910923 BCD ADVANCED
K901548 BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
K903435 SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K901624 SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.
K901250 PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR
K901249 PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
K900797 STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
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