GAS MODULE SE, MODEL 0998-00-0481-02— 510(k) K062754

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K062754 for GAS MODULE SE, MODEL 0998-00-0481-02, Substantially Equivalent on 2006-11-02. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 2006-09-14
Decision date: 2006-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwh, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.