BIPAP VISION VENTILATORY SUPPORT— 510(k) K982454
Substantially Equivalent - Subject to Tracking Reg.Respironics, Inc.
FDA 510(k) clearance K982454 for BIPAP VISION VENTILATORY SUPPORT, Substantially Equivalent - Subject to Tracking Reg. on 1998-11-03. Applicant: Respironics, Inc..
Clearance details
- Applicant
- Respironics, Inc.
- Product code
- Code MNT
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
Adverse events under product code MNT
product code MNT- Death
- 118
- Injury
- 324
- Malfunction
- 25,451
- Other
- 2
- Total
- 25,895
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.