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

PATIENT GAS SAMPLING LINE FOR OHMEDA 6000

K Number: K910509 · Decision Apr 17, 1991
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
29
Review Days
71

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Basic Information

Device Name
PATIENT GAS SAMPLING LINE FOR OHMEDA 6000
K Number
K910509
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1400
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Intertech Resources, Inc.
Date Received
February 5, 1991
Decision Date
April 17, 1991
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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Other Clearances by Intertech Resources, Inc.

K Number Device Name
K961318 1ST RESPONSE DISPOSABLE MANOMETER
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K953580 HEAT MOISTURE EXCHANGER
K952223 XENON GAS BREATHING CIRCUIT
K952062 PFT FILTER
K952169 SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
K952214 SIMS INTERTECH HYPERINFLATION BAG SYSTEM
K935036 HEPA FILTERED HEAT AND MOISTURE EXCHANGER
K930816 HEPA FILTERED HME
K922479 DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
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