Polso Watch

Oximeter

Chronisense Medical, Ltd.

The following data is part of a premarket notification filed by Chronisense Medical, Ltd. with the FDA for Polso Watch.

Pre-market Notification Details

Device IDK220351
510k NumberK220351
Device Name:Polso Watch
ClassificationOximeter
Applicant Chronisense Medical, Ltd. 2 Hacarmel St. P.O.B. 399 Yokneam Illit,  IL 2066724
ContactBridget Ross
CorrespondentAllison Komiyama
RQM+ 2251 San Diego Ave. Ste B-257 San Diego,  CA  92110
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-07
Decision Date2022-11-18

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