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FDA 510(k)

DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11

K-Number: K014141 · 2002-09-13

ApplicantDigibio Technology Corp.
Decision Date2002-09-13
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 is the device name listed in this FDA 510(k) record. The listed applicant is Digibio Technology Corp.. It received FDA 510(k) clearance on 2002-09-13 under 510(k) number K014141. 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 DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11?

DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 is a medical device that received FDA 510(k) clearance on 2002-09-13. The listed applicant is Digibio Technology Corp.. The 510(k) number is K014141.

When did DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 receive FDA 510(k) clearance?

DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 received FDA 510(k) clearance on 2002-09-13, under 510(k) number K014141.

Who is the listed applicant for DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11?

The FDA 510(k) record lists Digibio Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11?

The FDA product code for DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 is DXN.

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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

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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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