RESPIRONICS RESCUE DOME— 510(k) K833328
Substantially EquivalentRespironics, Inc.
FDA 510(k) clearance K833328 for RESPIRONICS RESCUE DOME, Substantially Equivalent on 1983-12-16. Applicant: Respironics, Inc.. Device class: 1.
Clearance details
- Applicant
- Respironics, Inc.
- Product code
- Code CAE
- Device class
- Class 1
- Regulation
- 21 CFR 868.5110
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroeville, PA, US
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More clearances from Respironics, Inc.
view allAdverse events under product code CAE
product code CAE- Death
- 4
- Total
- 4
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.