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FDA 510(k)

NICAS(TM) ELECTRODE

K-Number: K972001 · 1997-07-08

ApplicantNi Medical
Decision Date1997-07-08
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NICAS(TM) ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Ni Medical. It received FDA 510(k) clearance on 1997-07-08 under 510(k) number K972001. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICAS(TM) ELECTRODE?

NICAS(TM) ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-07-08. The listed applicant is Ni Medical. The 510(k) number is K972001.

When did NICAS(TM) ELECTRODE receive FDA 510(k) clearance?

NICAS(TM) ELECTRODE received FDA 510(k) clearance on 1997-07-08, under 510(k) number K972001.

Who is the listed applicant for NICAS(TM) ELECTRODE?

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

What is the FDA product code for NICAS(TM) ELECTRODE?

The FDA product code for NICAS(TM) ELECTRODE is DRX.

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 Ni Medical 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.

K070500BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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