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

MONITOR, PATIENT, RESP. CARBON DIOXIDE

K Number: K770713 · Decision Apr 27, 1977
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
32
Review Days
9

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Basic Information

Device Name
MONITOR, PATIENT, RESP. CARBON DIOXIDE
K Number
K770713
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1400
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Cavitron Corp.
Date Received
April 18, 1977
Decision Date
April 27, 1977
Product Code
CCK
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
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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K801877 SLIT LAMP ATTACHMENT
K800869 MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA
K800722 AUTO-FIELD D AUTOMATED VISUAL DETECTOR
K791585 MODEL G-61 ULTRASONIC DENTAL UNIT
K791277 MODEL 6500 EXTRACTION IRRIGATION SYS
K782054 LASER, CO2 SURGICAL
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