BPBIO750
K-Number: K231174 · 2023-08-02
ApplicantInbody Co., Ltd.
Decision Date2023-08-02
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
BPBIO750 is a medical device manufactured by Inbody Co., Ltd.. It received FDA 510(k) clearance on 2023-08-02 under approval number K231174. 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 BPBIO750?
BPBIO750 is a medical device that received FDA 510(k) clearance on 2023-08-02. It is manufactured by Inbody Co., Ltd.. The 510(k) number is K231174.
When was BPBIO750 approved by the FDA?
BPBIO750 received FDA 510(k) clearance on 2023-08-02, under approval number K231174.
What company makes BPBIO750?
BPBIO750 is manufactured by Inbody Co., Ltd..
What is the FDA product code for BPBIO750?
The FDA product code for BPBIO750 is DXN.
Other Devices by Inbody Co., Ltd.
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.