ADIDYNE 3000— 510(k) K771707

Substantially Equivalent

Timeter Instrument Corp.

FDA 510(k) clearance K771707 for ADIDYNE 3000, Substantially Equivalent on 1977-09-26. Applicant: Timeter Instrument Corp..

Clearance details

Applicant: Timeter Instrument Corp.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 1977-09-09
Decision date: 1977-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.