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FDA 510(k)

RECORDER, HOLTER ELECTROCARDIOGRAM

K-Number: K781843 · 1978-11-03

ApplicantHovik Corp.
Decision Date1978-11-03
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RECORDER, HOLTER ELECTROCARDIOGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Hovik Corp.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781843. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECORDER, HOLTER ELECTROCARDIOGRAM?

RECORDER, HOLTER ELECTROCARDIOGRAM is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Hovik Corp.. The 510(k) number is K781843.

When did RECORDER, HOLTER ELECTROCARDIOGRAM receive FDA 510(k) clearance?

RECORDER, HOLTER ELECTROCARDIOGRAM received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781843.

Who is the listed applicant for RECORDER, HOLTER ELECTROCARDIOGRAM?

The FDA 510(k) record lists Hovik Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RECORDER, HOLTER ELECTROCARDIOGRAM?

The FDA product code for RECORDER, HOLTER ELECTROCARDIOGRAM is DSH.

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Related Devices (Code: DSH)

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

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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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