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FDA 510(k)

IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS

K-Number: K083347 · 2008-12-24

ApplicantFluke Biomedical
Decision Date2008-12-24
Product CodeDRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS is the device name listed in this FDA 510(k) record. The listed applicant is Fluke Biomedical. It received FDA 510(k) clearance on 2008-12-24 under 510(k) number K083347. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS?

IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS is a medical device that received FDA 510(k) clearance on 2008-12-24. The listed applicant is Fluke Biomedical. The 510(k) number is K083347.

When did IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS receive FDA 510(k) clearance?

IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS received FDA 510(k) clearance on 2008-12-24, under 510(k) number K083347.

Who is the listed applicant for IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS?

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

What is the FDA product code for IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS?

The FDA product code for IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS is DRL.

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 Fluke Biomedical 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.

K121860ESA615K121722ESA620 ELECTRICAL SAFETY ANALYZERK110429PROSIM 4, PROSIM 6, PROSIM 8K103336MPS450 MULTIPARAMETER SIMULATORK072114IMPULSE 6000D/7000DP

Related Devices (Code: DRL)

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.

K190437Delta 3300Netech CorporationK182905UniPulseSeaward GroupK110192DEFIBRILLATOR ANALYZER - DA-2006PBc Group International, Inc.K072114IMPULSE 6000D/7000DPFluke BiomedicalK062099PHASE 3, MODEL DT-1Datrend Systems, Inc.K030547MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBEGuardian Angel Products, 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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