510(k) K844557— ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE

Substantially Equivalent

Ackrad Laboratories

Clearance details

Applicant: Ackrad Laboratories
Product code: Code BSR
Advisory panel: Anesthesiology
Date received: 1984-11-21
Decision date: 1984-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranford, NJ, US

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.