AIRWAY SUPPORT SYSTEM / AIRPORT

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

ABEON MEDICAL CORPORATION

The following data is part of a premarket notification filed by Abeon Medical Corporation with the FDA for Airway Support System / Airport.

Pre-market Notification Details

Device IDK131506
510k NumberK131506
Device Name:AIRWAY SUPPORT SYSTEM / AIRPORT
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant ABEON MEDICAL CORPORATION 8000 KATHERINE BOULEVARD Brecksville,  OH  44141
ContactAllison Slaga
CorrespondentAllison Slaga
ABEON MEDICAL CORPORATION 8000 KATHERINE BOULEVARD Brecksville,  OH  44141
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-24
Decision Date2014-03-06

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