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FDA 510(k)

EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391

K-Number: K971570 · 1997-12-29

ApplicantQuinton Electrophysiology Corp.
Decision Date1997-12-29
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 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 1997-12-29 under 510(k) number K971570. 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 EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391?

EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 is a medical device that received FDA 510(k) clearance on 1997-12-29. The listed applicant is Quinton Electrophysiology Corp.. The 510(k) number is K971570.

When did EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 receive FDA 510(k) clearance?

EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 received FDA 510(k) clearance on 1997-12-29, under 510(k) number K971570.

Who is the listed applicant for EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391?

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 EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391?

The FDA product code for EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 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.

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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.

K925346EP AMP, MODEL #901K893836EPLAB (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.K925346EP AMP, MODEL #901Quinton 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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