Endoscopy Oxygen Mask

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

Engineered Medical Systems Inc.

The following data is part of a premarket notification filed by Engineered Medical Systems Inc. with the FDA for Endoscopy Oxygen Mask.

Pre-market Notification Details

Device IDK220533
510k NumberK220533
Device Name:Endoscopy Oxygen Mask
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant Engineered Medical Systems Inc. 2055 Executive Dr Indianapolis,  IN  46241
ContactTamara Lefevers
CorrespondentPaul Dryden
ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg,  FL  33704
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-24
Decision Date2022-11-16

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