SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT— 510(k) K945407
Substantially EquivalentMallinckrodt Medical Tpi, Inc.
FDA 510(k) clearance K945407 for SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT, Substantially Equivalent on 1995-02-27. Applicant: Mallinckrodt Medical Tpi, Inc.. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Medical Tpi, Inc.
- Product code
- Code BTO
- Device class
- Class 2
- Regulation
- 21 CFR 868.5800
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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More clearances from Mallinckrodt Medical Tpi, Inc.
view allAdverse events under product code BTO
product code BTO- Death
- 14
- Injury
- 328
- Malfunction
- 1,851
- Total
- 2,193
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.