RESPAKIT— 510(k) K892053
Substantially EquivalentProtectical Health & Safety , Ltd.
FDA 510(k) clearance K892053 for RESPAKIT, Substantially Equivalent on 1989-04-27. Applicant: Protectical Health & Safety , Ltd..
Clearance details
- Applicant
- Protectical Health & Safety , Ltd.
- Product code
- Code CAE
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Adverse 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.