HEM-7311

System, Measurement, Blood-pressure, Non-invasive

OMRON HEALTHCARE, INC.

The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Hem-7311.

Pre-market Notification Details

Device IDK133379
510k NumberK133379
Device Name:HEM-7311
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant OMRON HEALTHCARE, INC. 24301 WOODSAGE DR. Bonita Springs,  FL  34134
ContactPaul Dryden
CorrespondentPaul Dryden
OMRON HEALTHCARE, INC. 24301 WOODSAGE DR. Bonita Springs,  FL  34134
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-04
Decision Date2014-01-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00681131895408 K133379 000
10073796710023 K133379 000
10073796267251 K133379 000
10073796725317 K133379 000
10073796267206 K133379 000
00073796100315 K133379 000
10073796711020 K133379 000
00073796930004 K133379 000
10073796272552 K133379 000
10073796271500 K133379 000
10073796251502 K133379 000
10073796251007 K133379 000
00073796265359 K133379 000
00073796920005 K133379 000
00073796765316 K133379 000
00073796742348 K133379 000
00073796710347 K133379 000
00073796710217 K133379 000
00073796343996 K133379 000
00073796343170 K133379 000
00073796274245 K133379 000
00073796271046 K133379 000
10073796265455 K133379 000
10073796250000 K133379 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.