WesperO2

Oximeter

Wesper Inc.

The following data is part of a premarket notification filed by Wesper Inc. with the FDA for Wespero2.

Pre-market Notification Details

Device IDK213515
510k NumberK213515
Device Name:WesperO2
ClassificationOximeter
Applicant Wesper Inc. 234 5th Ave New York,  NY  10001
ContactAmir Reuveny
CorrespondentAmir Reuveny
Wesper Inc. 234 5th Ave New York,  NY  10001
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-02
Decision Date2022-06-10

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