DALE ENDOTRACHEAL TUBE HOLDER 270/280— 510(k) K964399

Name: FDA 510(k) clearance K964399
Creator: U.S. Food and Drug Administration
Published: 1997-01-28

Substantially Equivalent

Dale Medical Products, Inc.

FDA 510(k) clearance K964399 for DALE ENDOTRACHEAL TUBE HOLDER 270/280, Substantially Equivalent on 1997-01-28. Applicant: Dale Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Dale Medical Products, Inc.
Product code: Code CBH
Device class: Class 1
Regulation: 21 CFR 868.5770
Advisory panel: Anesthesiology
Date received: 1996-11-04
Decision date: 1997-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainville, MA, 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.