Cleared Traditional

COMPUMEDICS SOMTE SYSTEM

K021176 · Compumedics Limited · Anesthesiology
Jan 2003
Decision
284d
Days
Class 2
Risk

About This 510(k) Submission

K021176 is an FDA 510(k) clearance for the COMPUMEDICS SOMTE SYSTEM, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Compumedics Limited (Minneapolis,, US). The FDA issued a Cleared decision on January 21, 2003, 284 days after receiving the submission on April 12, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K021176 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2002
Decision Date January 21, 2003
Days to Decision 284 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375