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FDA 510(k)

PC ECG 1200W SYSTEM

K-Number: K080141 · 2008-04-25

ApplicantNorav Medical , Ltd.
Decision Date2008-04-25
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PC ECG 1200W SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Norav Medical , Ltd.. It received FDA 510(k) clearance on 2008-04-25 under 510(k) number K080141. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PC ECG 1200W SYSTEM?

PC ECG 1200W SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-25. The listed applicant is Norav Medical , Ltd.. The 510(k) number is K080141.

When did PC ECG 1200W SYSTEM receive FDA 510(k) clearance?

PC ECG 1200W SYSTEM received FDA 510(k) clearance on 2008-04-25, under 510(k) number K080141.

Who is the listed applicant for PC ECG 1200W SYSTEM?

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

What is the FDA product code for PC ECG 1200W SYSTEM?

The FDA product code for PC ECG 1200W SYSTEM is MWI.

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 Norav Medical , 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.

K110463PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)K012712NORAV HOLTER SYSTEM, MODEL NH-300 V1.07K000404PC ECG 1200

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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