Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR

K-Number: K081891 · 2008-08-29

ApplicantFukuda Denshi USA, Inc.
Decision Date2008-08-29
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 2008-08-29 under 510(k) number K081891. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR?

FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2008-08-29. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K081891.

When did FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR receive FDA 510(k) clearance?

FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR received FDA 510(k) clearance on 2008-08-29, under 510(k) number K081891.

Who is the listed applicant for FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR?

The FDA 510(k) record lists Fukuda Denshi USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR?

The FDA product code for FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR is MHX.

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 Fukuda Denshi USA, Inc. 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.

K173226CardiMax ElectrocardiographK112521FUKUDA DENSHI VASERA MODEL VS-1500K103134FUKUDA DENSHIK083697FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210MK082656MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNITK050363FUKUDA DENSHI MODEL UF-850XTD

View all 66 devices →

Related Devices (Code: MHX)

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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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.

↑