HD Steth

Stethoscope, Electronic

HD Medical, Inc.

The following data is part of a premarket notification filed by Hd Medical, Inc. with the FDA for Hd Steth.

Pre-market Notification Details

Device IDK201299
510k NumberK201299
Device Name:HD Steth
ClassificationStethoscope, Electronic
Applicant HD Medical, Inc. 3561 Homestead Road #146 Santa Clara,  CA  95051
ContactStephanie Anderson
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDQD  
CFR Regulation Number870.1875 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-05-15
Decision Date2020-07-10

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