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

Clearance details

Applicant

Datascope Corp.

Product code

Code BZK

Device class

Class 2

Regulation

21 CFR 868.1850

Advisory panel

Anesthesiology

Date received

2006-09-14

Decision date

2006-11-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mahwh, NJ, US

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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 →

• Z-1242-2018 — Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.Class III·Terminated·Mindray DS USA, Inc. dba Mindray North America·20171201

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062754.