CASSETTE TAPE REPLAY SYSTEM— 510(k) K870554

Substantially Equivalent

Research Instrumentation Associates, Inc.

FDA 510(k) clearance K870554 for CASSETTE TAPE REPLAY SYSTEM, Substantially Equivalent on 1987-03-23. Applicant: Research Instrumentation Associates, Inc..

Clearance details

Applicant: Research Instrumentation Associates, Inc.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1987-02-10
Decision date: 1987-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beachwood, OH, US

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Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.