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FDA 510(k)

CARDIACINDEX COMPUTER MODEL SP 1435

K-Number: K802476 · 1980-11-19

ApplicantGould, Inc.
Decision Date1980-11-19
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIACINDEX COMPUTER MODEL SP 1435 is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1980-11-19 under 510(k) number K802476. 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 CARDIACINDEX COMPUTER MODEL SP 1435?

CARDIACINDEX COMPUTER MODEL SP 1435 is a medical device that received FDA 510(k) clearance on 1980-11-19. The listed applicant is Gould, Inc.. The 510(k) number is K802476.

When did CARDIACINDEX COMPUTER MODEL SP 1435 receive FDA 510(k) clearance?

CARDIACINDEX COMPUTER MODEL SP 1435 received FDA 510(k) clearance on 1980-11-19, under 510(k) number K802476.

Who is the listed applicant for CARDIACINDEX COMPUTER MODEL SP 1435?

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 CARDIACINDEX COMPUTER MODEL SP 1435?

The FDA product code for CARDIACINDEX COMPUTER MODEL SP 1435 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.

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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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