Strados Remote Electronic Stethoscope Platform (RESP)

Recorder, Magnetic Tape, Medical

Strados Labs, Inc.

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

Pre-market Notification Details

Device IDK220893
510k NumberK220893
Device Name:Strados Remote Electronic Stethoscope Platform (RESP)
ClassificationRecorder, Magnetic Tape, Medical
Applicant Strados Labs, Inc. 1315 Walnut Street, Suite 1101 Philadelphia,  PA  19107
ContactNicholas Delmonico
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-03-28
Decision Date2022-04-27

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