RESPIRONICS SANDERS BIPAPEASY— 510(k) K871523

Name: FDA 510(k) clearance K871523
Creator: U.S. Food and Drug Administration
Published: 1987-07-16

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K871523 for RESPIRONICS SANDERS BIPAPEASY, Substantially Equivalent on 1987-07-16. Applicant: Respironics, Inc.. Device class: 2.

Clearance details

Applicant: Respironics, Inc.
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1987-04-20
Decision date: 1987-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

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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.