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FDA 510(k)

FINOMETER MODEL-2 WITH ACCESSORIES

K-Number: K063111 · 2007-02-01

ApplicantFinapres Medical Systems B.V.
Decision Date2007-02-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FINOMETER MODEL-2 WITH ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Finapres Medical Systems B.V.. It received FDA 510(k) clearance on 2007-02-01 under 510(k) number K063111. 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 FINOMETER MODEL-2 WITH ACCESSORIES?

FINOMETER MODEL-2 WITH ACCESSORIES is a medical device that received FDA 510(k) clearance on 2007-02-01. The listed applicant is Finapres Medical Systems B.V.. The 510(k) number is K063111.

When did FINOMETER MODEL-2 WITH ACCESSORIES receive FDA 510(k) clearance?

FINOMETER MODEL-2 WITH ACCESSORIES received FDA 510(k) clearance on 2007-02-01, under 510(k) number K063111.

Who is the listed applicant for FINOMETER MODEL-2 WITH ACCESSORIES?

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

What is the FDA product code for FINOMETER MODEL-2 WITH ACCESSORIES?

The FDA product code for FINOMETER MODEL-2 WITH ACCESSORIES 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 Finapres Medical Systems 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.

K173916Finapres Nova Noninvasive Hemodynamic MonitorK160967Finapres Nova Noninvasive Hemodynamic Monitor

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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