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

COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM

K Number: K852102 · Decision Jul 31, 1985
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
10
Applicant Total
14
Review Days
77

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Basic Information

Device Name
COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM
K Number
K852102
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1750
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Warren E. Collins, Inc.
Date Received
May 15, 1985
Decision Date
July 31, 1985
Product Code
CCM
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
CCM Plethysmograph, Pressure

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K861227 COLLINS PNEUMOTACH PFT SYSTEM
K831780 METABOLIC EXERCISE TESTING SYSTEM
K831777 COLLINS DS
K831778 RS-RESIDUAL VOLUME SYSTEM
K831779 COLLINS EAGLE II
K803053 APEXLINE OF PULMONARY FUNCT. INSTRUM.
K803069 SHELL KRATON THERMO-PLASTIC RUBBER COMP.
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