Pivot Breath Sensor

Analyzer, Gas, Carbon-monoxide, Gaseous-phase

Carrot Inc.

The following data is part of a premarket notification filed by Carrot Inc. with the FDA for Pivot Breath Sensor.

Pre-market Notification Details

Device IDK201206
510k NumberK201206
Device Name:Pivot Breath Sensor
ClassificationAnalyzer, Gas, Carbon-monoxide, Gaseous-phase
Applicant Carrot Inc. 1400A Seaport Blvd, Suite 501 Redwood City,  CA  94063
ContactSara Lippert
CorrespondentJonathan S. Kahan
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeCCJ  
CFR Regulation Number868.1430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-04
Decision Date2021-06-30

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