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FDA 510(k)

DISK

K-Number: K812695 · 1981-10-13

ApplicantAmerican Heartline, Inc.
Decision Date1981-10-13
Product Code
DecisionSubstantially Equivalent

Device Summary

DISK is the device name listed in this FDA 510(k) record. The listed applicant is American Heartline, Inc.. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812695. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISK?

DISK is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is American Heartline, Inc.. The 510(k) number is K812695.

When did DISK receive FDA 510(k) clearance?

DISK received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812695.

Who is the listed applicant for DISK?

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

Other records listing American Heartline, 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.

K822856VITALINE 2

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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