PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT— 510(k) K990905

Substantially Equivalent

Passy-Muir, Inc.

FDA 510(k) clearance K990905 for PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT, Substantially Equivalent on 1999-06-11. Applicant: Passy-Muir, Inc..

Clearance details

Applicant: Passy-Muir, Inc.
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 1999-03-18
Decision date: 1999-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.