TRACH COLLAR— 510(k) K872832

Name: FDA 510(k) clearance K872832
Creator: U.S. Food and Drug Administration
Published: 1987-09-04

Substantially Equivalent

Rotek Corp.

FDA 510(k) clearance K872832 for TRACH COLLAR, Substantially Equivalent on 1987-09-04. Applicant: Rotek Corp.. Device class: 1.

Clearance details

Applicant: Rotek Corp.
Product code: Code CBH
Device class: Class 1
Regulation: 21 CFR 868.5770
Advisory panel: Anesthesiology
Date received: 1987-07-17
Decision date: 1987-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, US

Download summary PDF View on FDA.gov ↗

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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.