DRAGER PEEP SYSTEM D— 510(k) K834085

Substantially Equivalent

Draeger Medical, Inc.

FDA 510(k) clearance K834085 for DRAGER PEEP SYSTEM D, Substantially Equivalent on 1983-12-16. Applicant: Draeger Medical, Inc..

Clearance details

Applicant: Draeger Medical, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1983-11-29
Decision date: 1983-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.