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FDA 510(k)

EP AMP, MODEL #901

K-Number: K925346 · 1993-04-30

ApplicantQuinton Electrophysiology Corp.
Decision Date1993-04-30
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EP AMP, MODEL #901 is the device name listed in this FDA 510(k) record. The listed applicant is Quinton Electrophysiology Corp.. It received FDA 510(k) clearance on 1993-04-30 under 510(k) number K925346. The device is classified under product code DRR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EP AMP, MODEL #901?

EP AMP, MODEL #901 is a medical device that received FDA 510(k) clearance on 1993-04-30. The listed applicant is Quinton Electrophysiology Corp.. The 510(k) number is K925346.

When did EP AMP, MODEL #901 receive FDA 510(k) clearance?

EP AMP, MODEL #901 received FDA 510(k) clearance on 1993-04-30, under 510(k) number K925346.

Who is the listed applicant for EP AMP, MODEL #901?

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

What is the FDA product code for EP AMP, MODEL #901?

The FDA product code for EP AMP, MODEL #901 is DRR.

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 Quinton Electrophysiology Corp. 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.

K971570EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391K893836EPLAB (ELECTROCARDIOGRAPHIC MONITOR)

Related Devices (Code: DRR)

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.

K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Biocheck, Inc.K971570EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391Quinton Electrophysiology Corp.K914381HORIZON 9000/HIS OPTION AMPLIFIERMennen Medical, Inc.K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDGould, Inc.K910307CARDIOLAB AMPLIFIER MODULE (CAM)Prucka Engineering, Inc.K894735ASC-952 PHYSIOLOGICAL AMPLIFIERAstro-Med, 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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