Cleared Traditional

MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS

K924875 · Synectics-Dantec · Anesthesiology
Jun 1994
Decision
654d
Days
Class 2
Risk

About This 510(k) Submission

K924875 is an FDA 510(k) clearance for the MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Synectics-Dantec (Irving, US). The FDA issued a Cleared decision on June 30, 1994, 654 days after receiving the submission on September 14, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K924875 FDA.gov
FDA Decision Cleared ST
Date Received September 14, 1992
Decision Date June 30, 1994
Days to Decision 654 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZQ — Monitor, Breathing Frequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375

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