ADULT RESUSCITATOR WITH MASK AND FILTER— 510(k) K884526

Substantially Equivalent

Intertech/Ohio

FDA 510(k) clearance K884526 for ADULT RESUSCITATOR WITH MASK AND FILTER, Substantially Equivalent on 1988-11-16. Applicant: Intertech/Ohio.

Clearance details

Applicant: Intertech/Ohio
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1988-10-27
Decision date: 1988-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, US

Download summary PDF View on FDA.gov ↗

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.