Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 And SA-09

System, Measurement, Blood-pressure, Non-invasive

Edan Instruments, Inc.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Ambulatory Blood Pressure Monitor, Models: Sa-10, Sa-05, Sa-06, Sa-08 And Sa-09.

Pre-market Notification Details

Device IDK210139
510k NumberK210139
Device Name:Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 And SA-09
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen,  CN 518122
ContactYing Dai
CorrespondentYing Dai
Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen,  CN 518122
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-10-01

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