K955516

Substantially Equivalent

MONTGOMERY TRACHEOSTOMY SPEAKING VALVE

Applicant: Boston Medical Products, Inc.
Product code: JOH
Advisory panel: Anesthesiology
Date received: 1995-12-04
Decision date: 1995-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

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.