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FDA 510(k)

HOLTER RECORDER & PLAYBACK/ANALYSIS SYS

K-Number: K822818 · 1982-12-30

ApplicantMarquette Electronics, Inc.
Decision Date1982-12-30
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER RECORDER & PLAYBACK/ANALYSIS SYS is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Electronics, Inc.. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K822818. 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 HOLTER RECORDER & PLAYBACK/ANALYSIS SYS?

HOLTER RECORDER & PLAYBACK/ANALYSIS SYS is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K822818.

When did HOLTER RECORDER & PLAYBACK/ANALYSIS SYS receive FDA 510(k) clearance?

HOLTER RECORDER & PLAYBACK/ANALYSIS SYS received FDA 510(k) clearance on 1982-12-30, under 510(k) number K822818.

Who is the listed applicant for HOLTER RECORDER & PLAYBACK/ANALYSIS SYS?

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

What is the FDA product code for HOLTER RECORDER & PLAYBACK/ANALYSIS SYS?

The FDA product code for HOLTER RECORDER & PLAYBACK/ANALYSIS SYS is DSH.

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Other records listing Marquette Electronics, Inc. as applicant

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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

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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