WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM

Transmitters And Receivers, Physiological Signal, Radiofrequency

SANITAS, INC.

The following data is part of a premarket notification filed by Sanitas, Inc. with the FDA for Wellaho Personalized Outpatient Management System.

Pre-market Notification Details

Device IDK123671
510k NumberK123671
Device Name:WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant SANITAS, INC. 11440 W. BERNARDO COURT, STE 300 San Diego,  CA  92127
ContactAlan Donald
CorrespondentAlan Donald
SANITAS, INC. 11440 W. BERNARDO COURT, STE 300 San Diego,  CA  92127
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-29
Decision Date2013-01-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860508000311 K123671 000

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