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FDA 510(k)

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819

K-Number: K172895 · 2018-06-18

ApplicantAgeless Health Industrial Co., Ltd.
Decision Date2018-06-18
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 is the device name listed in this FDA 510(k) record. The listed applicant is Ageless Health Industrial Co., Ltd.. It received FDA 510(k) clearance on 2018-06-18 under 510(k) number K172895. 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 AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819?

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 is a medical device that received FDA 510(k) clearance on 2018-06-18. The listed applicant is Ageless Health Industrial Co., Ltd.. The 510(k) number is K172895.

When did AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 receive FDA 510(k) clearance?

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 received FDA 510(k) clearance on 2018-06-18, under 510(k) number K172895.

Who is the listed applicant for AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819?

The FDA 510(k) record lists Ageless Health Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819?

The FDA product code for AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 is DXN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07696910Perioperative Hypoglycemia in Diabetic Patients Undergoing Vitrectomy: a Masked CGM Prospective Observational StudyNOT_YET_RECRUITINGNCT06313515Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCIRECRUITINGNCT07240831Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)RECRUITINGNCT07523269WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure ControlRECRUITINGNCT07694570Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor SystemNOT_YET_RECRUITINGNCT06469463Decoding Motor Imagery From Non-invasive Brain Recordings as a Prerequisite for Innovative Motor Rehabilitation TherapiesCOMPLETED

Other records listing Ageless Health Industrial Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172508Ageless Health Medical Digital ThermometerK153552AGE Automatic Upper Arm Blood Pressure Monitor

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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