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FDA 510(k)

MODEL SP1465 CARDIAC OUTPUT COMPUTER

K-Number: K861092 · 1986-08-18

ApplicantGould, Inc.
Decision Date1986-08-18
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL SP1465 CARDIAC OUTPUT COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1986-08-18 under 510(k) number K861092. 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 MODEL SP1465 CARDIAC OUTPUT COMPUTER?

MODEL SP1465 CARDIAC OUTPUT COMPUTER is a medical device that received FDA 510(k) clearance on 1986-08-18. The listed applicant is Gould, Inc.. The 510(k) number is K861092.

When did MODEL SP1465 CARDIAC OUTPUT COMPUTER receive FDA 510(k) clearance?

MODEL SP1465 CARDIAC OUTPUT COMPUTER received FDA 510(k) clearance on 1986-08-18, under 510(k) number K861092.

Who is the listed applicant for MODEL SP1465 CARDIAC OUTPUT COMPUTER?

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 MODEL SP1465 CARDIAC OUTPUT COMPUTER?

The FDA product code for MODEL SP1465 CARDIAC OUTPUT COMPUTER 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, MODIFIEDK860805PRESSURE 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: DXG)

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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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