RESUSCITATION BAG CONTROLLER (RBC)— 510(k) K882278

Substantially Equivalent

Physician Engineered Products, Inc.

FDA 510(k) clearance K882278 for RESUSCITATION BAG CONTROLLER (RBC), Substantially Equivalent on 1988-06-16. Applicant: Physician Engineered Products, Inc..

Clearance details

Applicant: Physician Engineered Products, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1988-06-01
Decision date: 1988-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Rapids, MN, 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.