Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ANSWATCH WRIST MONITOR MODEL TS-0411

K-Number: K123130 · 2013-09-17

ApplicantTaiwan Scientific Corporation
Decision Date2013-09-17
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANSWATCH WRIST MONITOR MODEL TS-0411 is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Scientific Corporation. It received FDA 510(k) clearance on 2013-09-17 under 510(k) number K123130. 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 ANSWATCH WRIST MONITOR MODEL TS-0411?

ANSWATCH WRIST MONITOR MODEL TS-0411 is a medical device that received FDA 510(k) clearance on 2013-09-17. The listed applicant is Taiwan Scientific Corporation. The 510(k) number is K123130.

When did ANSWATCH WRIST MONITOR MODEL TS-0411 receive FDA 510(k) clearance?

ANSWATCH WRIST MONITOR MODEL TS-0411 received FDA 510(k) clearance on 2013-09-17, under 510(k) number K123130.

Who is the listed applicant for ANSWATCH WRIST MONITOR MODEL TS-0411?

The FDA 510(k) record lists Taiwan Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANSWATCH WRIST MONITOR MODEL TS-0411?

The FDA product code for ANSWATCH WRIST MONITOR MODEL TS-0411 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Taiwan Scientific Corporation 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.

K201914HRVWatch-Mini Wrist 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.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.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.K261061BP Go (BPP-855)Wellvii, Inc.

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.

↑