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FDA 510(k)

ADVANTAGE 3000

K-Number: K973355 · 1997-12-05

ApplicantAdvantage Medical Division of Cme Telemetrix
Decision Date1997-12-05
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Advantage Medical Division of Cme Telemetrix. It received FDA 510(k) clearance on 1997-12-05 under 510(k) number K973355. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTAGE 3000?

ADVANTAGE 3000 is a medical device that received FDA 510(k) clearance on 1997-12-05. The listed applicant is Advantage Medical Division of Cme Telemetrix. The 510(k) number is K973355.

When did ADVANTAGE 3000 receive FDA 510(k) clearance?

ADVANTAGE 3000 received FDA 510(k) clearance on 1997-12-05, under 510(k) number K973355.

Who is the listed applicant for ADVANTAGE 3000?

The FDA 510(k) record lists Advantage Medical Division of Cme Telemetrix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANTAGE 3000?

The FDA product code for ADVANTAGE 3000 is IKN.

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 Advantage Medical Division of Cme Telemetrix 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.

K974010ADVANTAGE EMG SYSTEM, MODEL #A100

Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, Inc.

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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