Blood Pressure Monitor

System, Measurement, Blood-pressure, Non-invasive

Bioland Technology Ltd.

The following data is part of a premarket notification filed by Bioland Technology Ltd. with the FDA for Blood Pressure Monitor.

Pre-market Notification Details

Device IDK202934
510k NumberK202934
Device Name:Blood Pressure Monitor
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen,  CN 518116
ContactYiqing Feng
CorrespondentYiqing Feng
Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen,  CN 518116
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-01-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000
16939184610082 K202934 000

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