FAHL TRACHEOSTOMY TUBES (MULTIPLE)— 510(k) K123699
Substantially EquivalentAndreas Fahl Medizintechnik-Vertrieb GmbH
FDA 510(k) clearance K123699 for FAHL TRACHEOSTOMY TUBES (MULTIPLE), Substantially Equivalent on 2013-08-12. Applicant: Andreas Fahl Medizintechnik-Vertrieb GmbH.
Clearance details
- Applicant
- Andreas Fahl Medizintechnik-Vertrieb GmbH
- Product code
- Code JOH
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Koeln, DE
Adverse events under product code JOH
product code JOH- Death
- 42
- Injury
- 1,344
- Malfunction
- 5,608
- Other
- 1
- Total
- 6,995
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.