CPAP SYSTEM, MODEL 102001— 510(k) K001318

Substantially Equivalent

Sims Portex, Inc.

FDA 510(k) clearance K001318 for CPAP SYSTEM, MODEL 102001, Substantially Equivalent on 2000-07-20. Applicant: Sims Portex, Inc..

Clearance details

Applicant: Sims Portex, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 2000-04-26
Decision date: 2000-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, 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.