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FDA 510(k)

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device

K-Number: K181832 · 2019-04-09

ApplicantGuangdong Transtek Medical Electronics Co., Ltd.
Decision Date2019-04-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-04-09 under 510(k) number K181832. 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; Welch Allyn 901123 Digital Blood Pressure Device?

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is a medical device that received FDA 510(k) clearance on 2019-04-09. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K181832.

When did Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device receive FDA 510(k) clearance?

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device received FDA 510(k) clearance on 2019-04-09, under 510(k) number K181832.

Who is the listed applicant for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device?

The FDA 510(k) record lists Guangdong Transtek Medical 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; Welch Allyn 901123 Digital Blood Pressure Device?

The FDA product code for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is DXN.

Other records listing Guangdong Transtek Medical Electronics Co., Ltd. as applicant

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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

View on FDA Database →

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

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