SSV PHONATE(TM) SHILEY SPEAKING VALVE— 510(k) K945406
Substantially EquivalentMallinckrodt Medical Tpi, Inc.
FDA 510(k) clearance K945406 for SSV PHONATE(TM) SHILEY SPEAKING VALVE, 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.