Strados Remote Electronic Stethoscope Platform (RESP)

Stethoscope, Electronic

Strados Labs

The following data is part of a premarket notification filed by Strados Labs with the FDA for Strados Remote Electronic Stethoscope Platform (resp).

Pre-market Notification Details

Device IDK201077
510k NumberK201077
Device Name:Strados Remote Electronic Stethoscope Platform (RESP)
ClassificationStethoscope, Electronic
Applicant Strados Labs 1315 Walnut Street, Suite 1101 Philadelphia,  PA  19107
ContactNicholas Delmonico
CorrespondentGrace Powers
Powers Regulatory Consulting|64954 2451 Cumberland Parkway SE Suite 3740 Atlanta,  GA  30339
Product CodeDQD  
CFR Regulation Number870.1875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-22
Decision Date2020-12-20

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