SULLIVAN NASAL CPAP SYSTEM— 510(k) K882292

Substantially Equivalent

Baxter Centre For Medical Research

FDA 510(k) clearance K882292 for SULLIVAN NASAL CPAP SYSTEM, Substantially Equivalent on 1988-06-21. Applicant: Baxter Centre For Medical Research.

Clearance details

Applicant: Baxter Centre For Medical Research
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1988-06-01
Decision date: 1988-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Ryde, N.S.W. 2113, AU

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.