Cleared Traditional

TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM

K093154 · Radiometer Medical Aps · Anesthesiology
Feb 2010
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K093154 is an FDA 510(k) clearance for the TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM, a Monitor, Carbon-dioxide, Cutaneous (Class II — Special Controls, product code LKD), submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on February 5, 2010, 122 days after receiving the submission on October 6, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2480.

Submission Details

510(k) Number K093154 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2009
Decision Date February 05, 2010
Days to Decision 122 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code LKD — Monitor, Carbon-dioxide, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2480

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