Arm Blood Pressure Monitor (model: BPM-A7VL)
K-Number: K243118 · 2024-11-26
Decision Date2024-11-26
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Arm Blood Pressure Monitor (model: BPM-A7VL) is a medical device manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-26 under approval number K243118. 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 Arm Blood Pressure Monitor (model: BPM-A7VL)?
Arm Blood Pressure Monitor (model: BPM-A7VL) is a medical device that received FDA 510(k) clearance on 2024-11-26. It is manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K243118.
When was Arm Blood Pressure Monitor (model: BPM-A7VL) approved by the FDA?
Arm Blood Pressure Monitor (model: BPM-A7VL) received FDA 510(k) clearance on 2024-11-26, under approval number K243118.
What company makes Arm Blood Pressure Monitor (model: BPM-A7VL)?
Arm Blood Pressure Monitor (model: BPM-A7VL) is manufactured by Shenzhen Imdk Medical Technology Co., Ltd..
What is the FDA product code for Arm Blood Pressure Monitor (model: BPM-A7VL)?
The FDA product code for Arm Blood Pressure Monitor (model: BPM-A7VL) 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.