TRACH COLLAR— 510(k) K904974

Substantially Equivalent

Rotek Corp.

FDA 510(k) clearance K904974 for TRACH COLLAR, Substantially Equivalent on 1991-01-11. Applicant: Rotek Corp..

Clearance details

Applicant: Rotek Corp.
Product code: Code CBH
Advisory panel: Anesthesiology
Date received: 1990-10-23
Decision date: 1991-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, US

Download summary PDF View on FDA.gov ↗

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.