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

ESOPHAGEAL OBTURATION AIRWAY

K Number: K761195 · Decision Dec 9, 1976
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
5
Review Days
3

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Basic Information

Device Name
ESOPHAGEAL OBTURATION AIRWAY
K Number
K761195
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5650
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Mckesson Corp.
Date Received
December 6, 1976
Decision Date
December 9, 1976
Product Code
CAO
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
CAO Airway, Esophageal (Obturator)

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Other Clearances by Mckesson Corp.

K Number Device Name
K771175 RESUSCITATOR, MS30
K761196 NITROUS OXIDE SCAVENGING MASK
K761194 HLR QUICK-FIT HEART-LUNG RESUSCITATOR
K760017 CONSIOUS SEDATION (ANALOR P-76)