MyHomeDoc

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

MyHomeDoc Ltd.

The following data is part of a premarket notification filed by Myhomedoc Ltd. with the FDA for Myhomedoc.

Pre-market Notification Details

Device IDK202483
510k NumberK202483
Device Name:MyHomeDoc
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant MyHomeDoc Ltd. 13 Zarchin St. Ra'anana,  IL 4366241
ContactOrly Maor
CorrespondentJonathan Kahan
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product Code510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &
Subsequent Product CodeDQA
Subsequent Product CodeDQD
Subsequent Product CodeERA
Subsequent Product CodeFLL
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-28
Decision Date2021-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290018446102 K202483 000
27290018446151 K202483 000
17290018446154 K202483 000

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