Digital Blood Pressure Monitor Models: B01, B02, B05 & B06T

System, Measurement, Blood-pressure, Non-invasive

Shenzhen Jamr Medical Technology CO., Limited

The following data is part of a premarket notification filed by Shenzhen Jamr Medical Technology Co., Limited with the FDA for Digital Blood Pressure Monitor Models: B01, B02, B05 & B06t.

Pre-market Notification Details

Device IDK172171
510k NumberK172171
Device Name:Digital Blood Pressure Monitor Models: B01, B02, B05 & B06T
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Shenzhen Jamr Medical Technology CO., Limited 2nd Floor, A-building, No.2 Guiyuan Road, Guihua Community, Guanlan Town, L Shenzhen,  CN 518110
ContactLi Xue
CorrespondentMei Tan
Chonconn Medical Device Consulting Co.LTD. 22A, HaiJing Square, No.18 Taizi Road, Nanshan District Shenzhen,  CN 518067
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-18
Decision Date2017-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16927709421015 K172171 000
16927709442133 K172171 000
16927709415069 K172171 000
16927709415038 K172171 000
16927709415045 K172171 000
16927709415052 K172171 000
16927709426171 K172171 000
16927709456079 K172171 000
16927709425051 K172171 000
06927709426136 K172171 000
10860002249626 K172171 000
16927709415083 K172171 000
16927709415076 K172171 000
16927709466023 K172171 000
16927709463176 K172171 000
16927709426195 K172171 000
10856471007225 K172171 000
16927709402380 K172171 000
16927709402397 K172171 000
10863398000284 K172171 000
16927709402359 K172171 000
16927709442140 K172171 000
16927709442157 K172171 000
16927709456093 K172171 000
00856324008426 K172171 000
16927709407248 K172171 000
16927709416073 K172171 000
16927709407170 K172171 000
16927709416059 K172171 000
06927709426051 K172171 000
16927709426089 K172171 000
16927709432097 K172171 000
16927709442072 K172171 000
16927709451029 K172171 000
06970845890057 K172171 000
06970845890125 K172171 000
00856324008099 K172171 000
06927709407142 K172171 000
06927709402291 K172171 000
16927709402274 K172171 000
06927709426105 K172171 000
06927709442129 K172171 000
00860001532708 K172171 000
00860001532739 K172171 000
16927709456055 K172171 000
06927709442112 K172171 000
10856471007096 K172171 000
06927709401324 K172171 000
16927709401369 K172171 000
06927709402260 K172171 000
00856471007075 K172171 000

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