HOOD SPEAKING VALVE— 510(k) K897059

Substantially Equivalent

Hood Laboratories

FDA 510(k) clearance K897059 for HOOD SPEAKING VALVE, Substantially Equivalent on 1990-03-12. Applicant: Hood Laboratories.

Clearance details

Applicant: Hood Laboratories
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 1989-12-18
Decision date: 1990-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pembroke, MA, US

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Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

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.