MODIFIED SANDERS BI-PAPEASY— 510(k) K883825

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K883825 for MODIFIED SANDERS BI-PAPEASY, Substantially Equivalent on 1988-12-08. Applicant: Respironics, Inc..

Clearance details

Applicant: Respironics, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1988-09-09
Decision date: 1988-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, 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.