APA Oxy Blade

Laryngoscope, Rigid

Venner Medical (Singapore) Pte Ltd

The following data is part of a premarket notification filed by Venner Medical (singapore) Pte Ltd with the FDA for Apa Oxy Blade.

Pre-market Notification Details

Device IDK191602
510k NumberK191602
Device Name:APA Oxy Blade
ClassificationLaryngoscope, Rigid
Applicant Venner Medical (Singapore) Pte Ltd 35 Joo Koon Circle Singapore,  SG 629110
ContactAdrian P. Waterton
CorrespondentChristine Brauer
Brauer Device Consultants, LLC 7 Trail House Court Rockville,  MD  20850
Product CodeCCW  
CFR Regulation Number868.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-17
Decision Date2019-08-02

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