UFIT TEN-10

System, Measurement, Blood-pressure, Non-invasive

BIOSIGN TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Biosign Technologies, Inc. with the FDA for Ufit Ten-10.

Pre-market Notification Details

Device IDK122443
510k NumberK122443
Device Name:UFIT TEN-10
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant BIOSIGN TECHNOLOGIES, INC. 9001 WESLEYAN RD, SUITE 200 Indianapolis,  IN  46268
ContactAllison Scott, Rac
CorrespondentAllison Scott, Rac
BIOSIGN TECHNOLOGIES, INC. 9001 WESLEYAN RD, SUITE 200 Indianapolis,  IN  46268
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-10
Decision Date2012-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00867661000318 K122443 000

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