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FDA 510(k)

COMPUTER, CARDIAC OUTPUT (#SP1425)

K-Number: K760532 · 1976-09-09

ApplicantGould, Inc.
Decision Date1976-09-09
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMPUTER, CARDIAC OUTPUT (#SP1425) is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1976-09-09 under 510(k) number K760532. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTER, CARDIAC OUTPUT (#SP1425)?

COMPUTER, CARDIAC OUTPUT (#SP1425) is a medical device that received FDA 510(k) clearance on 1976-09-09. The listed applicant is Gould, Inc.. The 510(k) number is K760532.

When did COMPUTER, CARDIAC OUTPUT (#SP1425) receive FDA 510(k) clearance?

COMPUTER, CARDIAC OUTPUT (#SP1425) received FDA 510(k) clearance on 1976-09-09, under 510(k) number K760532.

Who is the listed applicant for COMPUTER, CARDIAC OUTPUT (#SP1425)?

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 COMPUTER, CARDIAC OUTPUT (#SP1425)?

The FDA product code for COMPUTER, CARDIAC OUTPUT (#SP1425) is DXG.

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Other records listing Gould, 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.

K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDK861092MODEL SP1465 CARDIAC OUTPUT COMPUTERK860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORK854403MODEL 2120 SPIROSCREENK851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

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Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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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