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FDA 510(k)

QA-40M DEFIBRILLATOR TESTER

K-Number: K963190 · 1997-07-01

ApplicantMetron U.S., Inc.
Decision Date1997-07-01
Product CodeDRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QA-40M DEFIBRILLATOR TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Metron U.S., Inc.. It received FDA 510(k) clearance on 1997-07-01 under 510(k) number K963190. 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 QA-40M DEFIBRILLATOR TESTER?

QA-40M DEFIBRILLATOR TESTER is a medical device that received FDA 510(k) clearance on 1997-07-01. The listed applicant is Metron U.S., Inc.. The 510(k) number is K963190.

When did QA-40M DEFIBRILLATOR TESTER receive FDA 510(k) clearance?

QA-40M DEFIBRILLATOR TESTER received FDA 510(k) clearance on 1997-07-01, under 510(k) number K963190.

Who is the listed applicant for QA-40M DEFIBRILLATOR TESTER?

The FDA 510(k) record lists Metron U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QA-40M DEFIBRILLATOR TESTER?

The FDA product code for QA-40M DEFIBRILLATOR TESTER 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 Metron U.S., 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.

K982020METRON QA-IDS I.V. PUMP TESTERK973991METRON QA-510 SPO2 ANALYZERK963198PS-41 6M PATIENT SIMULATOR

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.K083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADSFluke BiomedicalK072114IMPULSE 6000D/7000DPFluke BiomedicalK062099PHASE 3, MODEL DT-1Datrend Systems, 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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