Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
K-Number: K210139 · 2021-10-01
ApplicantEdan Instruments, Inc.
Decision Date2021-10-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2021-10-01 under approval number K210139. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09?
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K210139.
When was Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 approved by the FDA?
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 received FDA 510(k) clearance on 2021-10-01, under approval number K210139.
What company makes Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09?
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 is manufactured by Edan Instruments, Inc..
What is the FDA product code for Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09?
The FDA product code for Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 is DXN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.