Cleared Traditional

DATASCOPE MULTINEX II

K926451 · Datascope Corp. · Anesthesiology
Aug 1993
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K926451 is an FDA 510(k) clearance for the DATASCOPE MULTINEX II, a Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (Class II — Special Controls, product code CBQ), submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on August 25, 1993, 244 days after receiving the submission on December 24, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1500.

Submission Details

510(k) Number K926451 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1992
Decision Date August 25, 1993
Days to Decision 244 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CBQ — Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1500

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