FAMILY HEALTHWARE

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 Family Healthware.

Pre-market Notification Details

Device IDK132173
510k NumberK132173
Device Name:FAMILY HEALTHWARE
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant SANITAS, INC. 11440 W. BERNARDO COURT, STE 300 San Diego,  CA  92027
ContactAlan Donald
CorrespondentAlan Donald
SANITAS, INC. 11440 W. BERNARDO COURT, STE 300 San Diego,  CA  92027
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-15
Decision Date2014-05-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860508000304 K132173 000

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