ENDO TRACHEA TUBE FIXATION— 510(k) K924551

Substantially Equivalent

M. Imonti and Associates Inc.,

FDA 510(k) clearance K924551 for ENDO TRACHEA TUBE FIXATION, Substantially Equivalent on 1992-12-08. Applicant: M. Imonti and Associates Inc.,.

Clearance details

Applicant: M. Imonti and Associates Inc.,
Product code: Code CBH
Advisory panel: Anesthesiology
Date received: 1992-09-09
Decision date: 1992-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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Adverse events under product code CBH

product code CBH

Death: 7
Total: 7

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.