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

GAS SAMPLING NASAL CANNULA

K Number: K900979 · Decision Mar 16, 1990
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
15
Review Days
14

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Basic Information

Device Name
GAS SAMPLING NASAL CANNULA
K Number
K900979
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1400
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Gibeck, Inc.
Date Received
March 2, 1990
Decision Date
March 16, 1990
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 Gibeck, Inc.

K Number Device Name
K965016 ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
K964377 THERMAL REGULATION SYSTEM BLANKET
K964382 HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
K960511 GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
K954828 ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
K953544 HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
K953491 HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
K952845 HUMID-VENT TRACH-VENT
K952844 HUMID-VENT 2
K952750 HUMID-VENT 1
Search all 15 clearances from Gibeck, Inc. →