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FDA 510(k)

HEARTBEATER

K-Number: K771924 · 1977-11-28

ApplicantDunn Instruments, Inc.
Decision Date1977-11-28
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTBEATER is the device name listed in this FDA 510(k) record. The listed applicant is Dunn Instruments, Inc.. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K771924. 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 HEARTBEATER?

HEARTBEATER is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Dunn Instruments, Inc.. The 510(k) number is K771924.

When did HEARTBEATER receive FDA 510(k) clearance?

HEARTBEATER received FDA 510(k) clearance on 1977-11-28, under 510(k) number K771924.

Who is the listed applicant for HEARTBEATER?

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

What is the FDA product code for HEARTBEATER?

The FDA product code for HEARTBEATER is DXG.

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Other records listing Dunn Instruments, 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.

K850184MEDICAL MULTI-IMAGE CAMERA-676K781214CAMERAS, MULTI-IMAGE

Related Devices (Code: DXG)

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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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