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)

TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995

K-Number: K101681 · 2011-05-27

ApplicantZhongshan Transtek Electronics Co., Ltd.
Decision Date2011-05-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Transtek Electronics Co., Ltd.. It received FDA 510(k) clearance on 2011-05-27 under 510(k) number K101681. 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 TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995?

TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Zhongshan Transtek Electronics Co., Ltd.. The 510(k) number is K101681.

When did TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 receive FDA 510(k) clearance?

TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 received FDA 510(k) clearance on 2011-05-27, under 510(k) number K101681.

Who is the listed applicant for TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995?

The FDA 510(k) record lists Zhongshan Transtek Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995?

The FDA product code for TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 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 Zhongshan Transtek Electronics 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.

K123780TRANSTEK BLOOD PRESSURE MONITORK123781TRANSTEK GLASS BODY FAT ANALYZERK123669TRANSTEK WRIST BLOOD PRESSURE MONITORK122482TRANSTEK WRIST BLOOD PRESSURE MONITORK121971WITHINGS, SMART BODY SCALEK120058TRANSTEK BLOOD PRESSURE MONITOR

View all 9 devices →

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.

↑