EDENTEC MODEL 2860 PRESSURE METER— 510(k) K891540

Substantially Equivalent

Edentec Corp.

FDA 510(k) clearance K891540 for EDENTEC MODEL 2860 PRESSURE METER, Substantially Equivalent on 1989-06-01. Applicant: Edentec Corp..

Clearance details

Applicant: Edentec Corp.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1989-03-17
Decision date: 1989-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.