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FDA 510(k)

UNISCAN 24 ECG ROCORDER

K-Number: K920572 · 1992-04-06

ApplicantUniscan , Ltd.
Decision Date1992-04-06
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNISCAN 24 ECG ROCORDER is the device name listed in this FDA 510(k) record. The listed applicant is Uniscan , Ltd.. It received FDA 510(k) clearance on 1992-04-06 under 510(k) number K920572. 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 UNISCAN 24 ECG ROCORDER?

UNISCAN 24 ECG ROCORDER is a medical device that received FDA 510(k) clearance on 1992-04-06. The listed applicant is Uniscan , Ltd.. The 510(k) number is K920572.

When did UNISCAN 24 ECG ROCORDER receive FDA 510(k) clearance?

UNISCAN 24 ECG ROCORDER received FDA 510(k) clearance on 1992-04-06, under 510(k) number K920572.

Who is the listed applicant for UNISCAN 24 ECG ROCORDER?

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

What is the FDA product code for UNISCAN 24 ECG ROCORDER?

The FDA product code for UNISCAN 24 ECG ROCORDER 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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