LOUISVILLE LABS OXYGEN HEAD TENT— 510(k) K955535

Substantially Equivalent

Louisville Laboratories, Inc.

FDA 510(k) clearance K955535 for LOUISVILLE LABS OXYGEN HEAD TENT, Substantially Equivalent on 1996-07-01. Applicant: Louisville Laboratories, Inc..

Clearance details

Applicant: Louisville Laboratories, Inc.
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 1995-12-05
Decision date: 1996-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

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Adverse events under product code CBF

product code CBF

Death: 6
Total: 6

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.