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FDA 510(k)

ELECTRONIC SPHYGMOMANOMETER

K-Number: K110774 · 2011-05-13

ApplicantContec Medical System Co., Ltd.
Decision Date2011-05-13
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC SPHYGMOMANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical System Co., Ltd.. It received FDA 510(k) clearance on 2011-05-13 under 510(k) number K110774. 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 ELECTRONIC SPHYGMOMANOMETER?

ELECTRONIC SPHYGMOMANOMETER is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is Contec Medical System Co., Ltd.. The 510(k) number is K110774.

When did ELECTRONIC SPHYGMOMANOMETER receive FDA 510(k) clearance?

ELECTRONIC SPHYGMOMANOMETER received FDA 510(k) clearance on 2011-05-13, under 510(k) number K110774.

Who is the listed applicant for ELECTRONIC SPHYGMOMANOMETER?

The FDA 510(k) record lists Contec Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRONIC SPHYGMOMANOMETER?

The FDA product code for ELECTRONIC SPHYGMOMANOMETER is DXN.

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Other records listing Contec Medical System 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.

K180837CONTEC Oxygen ConcentratorK101273DYNAMIC ECG SYSTEM MODEL TLC5000K110156AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,K101692PATIENT MONITORK101127PATIENT MONITOR, MODEL PM50K090936SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A

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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.

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.

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