INDEX BPM
K-Number: K221486 · 2022-08-30
ApplicantYa Horng Electronic Co., Ltd.
Decision Date2022-08-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
INDEX BPM is a medical device manufactured by Ya Horng Electronic Co., Ltd.. It received FDA 510(k) clearance on 2022-08-30 under approval number K221486. 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 INDEX BPM?
INDEX BPM is a medical device that received FDA 510(k) clearance on 2022-08-30. It is manufactured by Ya Horng Electronic Co., Ltd.. The 510(k) number is K221486.
When was INDEX BPM approved by the FDA?
INDEX BPM received FDA 510(k) clearance on 2022-08-30, under approval number K221486.
What company makes INDEX BPM?
INDEX BPM is manufactured by Ya Horng Electronic Co., Ltd..
What is the FDA product code for INDEX BPM?
The FDA product code for INDEX BPM is DXN.
Related Devices (Code: DXN)
K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc.
K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd.
K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd.
K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd.
K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited
K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.
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.