K014115

Substantially Equivalent

1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX

Applicant: Portex, Inc.
Product code: BTM
Advisory panel: Anesthesiology
Date received: 2001-12-14
Decision date: 2002-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.