CPAP SYSTEM, MODEL 102001— 510(k) K001318
Substantially EquivalentSims Portex, Inc.
FDA 510(k) clearance K001318 for CPAP SYSTEM, MODEL 102001, Substantially Equivalent on 2000-07-20. Applicant: Sims Portex, Inc.. Device class: 2.
Clearance details
- Applicant
- Sims Portex, Inc.
- Product code
- Code BYE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5965
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- 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, through . 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.