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FDA 510(k)

CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED

K-Number: K911935 · 1991-07-22

ApplicantGould, Inc.
Decision Date1991-07-22
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1991-07-22 under 510(k) number K911935. 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 CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED?

CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED is a medical device that received FDA 510(k) clearance on 1991-07-22. The listed applicant is Gould, Inc.. The 510(k) number is K911935.

When did CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED receive FDA 510(k) clearance?

CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED received FDA 510(k) clearance on 1991-07-22, under 510(k) number K911935.

Who is the listed applicant for CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED?

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

What is the FDA product code for CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED?

The FDA product code for CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED is DRR.

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Other records listing Gould, Inc. as applicant

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K861092MODEL SP1465 CARDIAC OUTPUT COMPUTERK860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORK854403MODEL 2120 SPIROSCREENK851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTXK850114C/PES 9201, ECG STRESS TESTING SYS

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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.K925346EP AMP, MODEL #901Quinton Electrophysiology Corp.K914381HORIZON 9000/HIS OPTION AMPLIFIERMennen Medical, 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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