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

RESUSCITATOR, MS30

K Number: K771175 · Decision Aug 2, 1977
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
207
Applicant Total
5
Review Days
34

Basic Information

Device Name
RESUSCITATOR, MS30
K Number
K771175
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5915
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
MCKESSON CORP.
Date Received
June 29, 1977
Decision Date
August 2, 1977
Product Code
BTM
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
BTM Ventilator, Emergency, Manual (Resuscitator)

Similar 510(k) Clearances

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Other Clearances by MCKESSON CORP.

K Number Device Name
K761196 NITROUS OXIDE SCAVENGING MASK
K761195 ESOPHAGEAL OBTURATION AIRWAY
K761194 HLR QUICK-FIT HEART-LUNG RESUSCITATOR
K760017 CONSIOUS SEDATION (ANALOR P-76)