ENDOTRACHEAL TUBE HOLDER— 510(k) K802601

Name: FDA 510(k) clearance K802601
Creator: U.S. Food and Drug Administration
Published: 1980-12-18

Substantially Equivalent

Hudson Oxygen Therapy Sales Co.

FDA 510(k) clearance K802601 for ENDOTRACHEAL TUBE HOLDER, Substantially Equivalent on 1980-12-18. Applicant: Hudson Oxygen Therapy Sales Co.. Device class: 1.

Clearance details

Applicant: Hudson Oxygen Therapy Sales Co.
Product code: Code CBH
Device class: Class 1
Regulation: 21 CFR 868.5770
Advisory panel: Anesthesiology
Date received: 1980-10-21
Decision date: 1980-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS1995-04-24
K950930 — TRACHE-TITE1995-03-22

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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.