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FDA 510(k)

ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE

K-Number: K902766 · 1991-03-12

ApplicantAdvanced Ischemia Recorders, Inc.
Decision Date1991-03-12
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Ischemia Recorders, Inc.. It received FDA 510(k) clearance on 1991-03-12 under 510(k) number K902766. 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 ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE?

ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE is a medical device that received FDA 510(k) clearance on 1991-03-12. The listed applicant is Advanced Ischemia Recorders, Inc.. The 510(k) number is K902766.

When did ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE receive FDA 510(k) clearance?

ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE received FDA 510(k) clearance on 1991-03-12, under 510(k) number K902766.

Who is the listed applicant for ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE?

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

What is the FDA product code for ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE?

The FDA product code for ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE 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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