DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM— 510(k) K893388
Substantially EquivalentDevilbiss Health Care, Inc.
FDA 510(k) clearance K893388 for DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM, Substantially Equivalent on 1989-06-23. Applicant: Devilbiss Health Care, Inc..
Clearance details
- Applicant
- Devilbiss Health Care, Inc.
- Product code
- Code BYE
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerset, PA, US
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.