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FDA 510(k)

NEXFIN MODEL 2

K-Number: K101123 · 2010-10-28

ApplicantBmeye B.V.
Decision Date2010-10-28
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEXFIN MODEL 2 is the device name listed in this FDA 510(k) record. The listed applicant is Bmeye B.V.. It received FDA 510(k) clearance on 2010-10-28 under 510(k) number K101123. 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 NEXFIN MODEL 2?

NEXFIN MODEL 2 is a medical device that received FDA 510(k) clearance on 2010-10-28. The listed applicant is Bmeye B.V.. The 510(k) number is K101123.

When did NEXFIN MODEL 2 receive FDA 510(k) clearance?

NEXFIN MODEL 2 received FDA 510(k) clearance on 2010-10-28, under 510(k) number K101123.

Who is the listed applicant for NEXFIN MODEL 2?

The FDA 510(k) record lists Bmeye B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEXFIN MODEL 2?

The FDA product code for NEXFIN MODEL 2 is DXN.

Related Clinical Trials

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Other records listing Bmeye B.V. 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.

K072049CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS

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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