PRIMED TRACHEOSTOMY TUBES (MULTIPLE)— 510(k) K120079

Substantially Equivalent

Primed Halberstadt Medizintechnik GmbH

FDA 510(k) clearance K120079 for PRIMED TRACHEOSTOMY TUBES (MULTIPLE), Substantially Equivalent on 2012-05-24. Applicant: Primed Halberstadt Medizintechnik GmbH.

Clearance details

Applicant: Primed Halberstadt Medizintechnik GmbH
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 2012-01-10
Decision date: 2012-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Halberstadt, DE

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Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.