SINGLE USE MANUAL RESUSCITATOR PEEP VALVE— 510(k) K932799

Substantially Equivalent

Engineered Medical Systems

FDA 510(k) clearance K932799 for SINGLE USE MANUAL RESUSCITATOR PEEP VALVE, Substantially Equivalent on 1993-09-03. Applicant: Engineered Medical Systems.

Clearance details

Applicant: Engineered Medical Systems
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1993-06-09
Decision date: 1993-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.