Cleared Traditional

GAS MODULE SE, MODEL 0998-00-0481-02

K062754 · Datascope Corp. · Anesthesiology
Nov 2006
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K062754 is an FDA 510(k) clearance for the GAS MODULE SE, MODEL 0998-00-0481-02, a Spirometer, Monitoring (w/wo Alarm) (Class II — Special Controls, product code BZK), submitted by Datascope Corp. (Mahwah, US). The FDA issued a Cleared decision on November 2, 2006, 49 days after receiving the submission on September 14, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1850.

Submission Details

510(k) Number K062754 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2006
Decision Date November 02, 2006
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZK — Spirometer, Monitoring (w/wo Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1850

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