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FDA 510(k)

Automatic Arm Bluetooth Blood Pressure Monitor

K-Number: K161846 · 2016-10-24

ApplicantTruly Instrument Limited
Decision Date2016-10-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Automatic Arm Bluetooth Blood Pressure Monitor is a medical device manufactured by Truly Instrument Limited. It received FDA 510(k) clearance on 2016-10-24 under approval number K161846. 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 Automatic Arm Bluetooth Blood Pressure Monitor?

Automatic Arm Bluetooth Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-10-24. It is manufactured by Truly Instrument Limited. The 510(k) number is K161846.

When was Automatic Arm Bluetooth Blood Pressure Monitor approved by the FDA?

Automatic Arm Bluetooth Blood Pressure Monitor received FDA 510(k) clearance on 2016-10-24, under approval number K161846.

What company makes Automatic Arm Bluetooth Blood Pressure Monitor?

Automatic Arm Bluetooth Blood Pressure Monitor is manufactured by Truly Instrument Limited.

What is the FDA product code for Automatic Arm Bluetooth Blood Pressure Monitor?

The FDA product code for Automatic Arm Bluetooth Blood Pressure Monitor is DXN.

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Related PubMed Literature

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Other Devices by Truly Instrument Limited

K192023Arm Blood Pressure Monitor K220276Infrared Thermometer TET-351

Related Devices (Code: 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.

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