ENDOTRACHEAL TUBE STYLET— 510(k) K921128

Substantially Equivalent

Eastmed Enterprises, Inc.

FDA 510(k) clearance K921128 for ENDOTRACHEAL TUBE STYLET, Substantially Equivalent on 1992-06-02. Applicant: Eastmed Enterprises, Inc..

Clearance details

Applicant: Eastmed Enterprises, Inc.
Product code: Code BSR
Advisory panel: Anesthesiology
Date received: 1992-03-10
Decision date: 1992-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlton, NJ, US

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Adverse events under product code BSR

product code BSR

Death: 2
Other: 1
Total: 3

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.