TRACHEOSTOMY TUBES, SHORT AND LONG TERM— 510(k) K791044
Substantially EquivalentExtracorporeal Medical Specialities, Inc.
FDA 510(k) clearance K791044 for TRACHEOSTOMY TUBES, SHORT AND LONG TERM, Substantially Equivalent on 1979-06-13. Applicant: Extracorporeal Medical Specialities, Inc..
Clearance details
- Applicant
- Extracorporeal Medical Specialities, Inc.
- Product code
- Code BTO
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse 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.