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FDA 510(k)

KANTRON 504 HEARTSTATION

K-Number: K812586 · 1981-12-29

ApplicantKantron Cardiovascular, Inc.
Decision Date1981-12-29
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KANTRON 504 HEARTSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Kantron Cardiovascular, Inc.. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K812586. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KANTRON 504 HEARTSTATION?

KANTRON 504 HEARTSTATION is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Kantron Cardiovascular, Inc.. The 510(k) number is K812586.

When did KANTRON 504 HEARTSTATION receive FDA 510(k) clearance?

KANTRON 504 HEARTSTATION received FDA 510(k) clearance on 1981-12-29, under 510(k) number K812586.

Who is the listed applicant for KANTRON 504 HEARTSTATION?

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

What is the FDA product code for KANTRON 504 HEARTSTATION?

The FDA product code for KANTRON 504 HEARTSTATION is LDD.

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 Kantron Cardiovascular, 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.

K812587MONO 2 OXYGEN MONITOR

Related Devices (Code: LDD)

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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