Cleared Special

MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES

K012837 · Datex-Ohmeda · Cardiovascular
Sep 2001
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K012837 is an FDA 510(k) clearance for the MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES, a Monitor, St Segment With Alarm (Class II — Special Controls, product code MLD), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on September 14, 2001, 22 days after receiving the submission on August 23, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K012837 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2001
Decision Date September 14, 2001
Days to Decision 22 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MLD — Monitor, St Segment With Alarm
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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