SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM— 510(k) K962492
Substantially EquivalentNidek Medical Products, Inc.
FDA 510(k) clearance K962492 for SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM, Substantially Equivalent on 1997-01-23. Applicant: Nidek Medical Products, Inc..
Clearance details
- Applicant
- Nidek Medical Products, Inc.
- Product code
- Code BYE
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, 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.