Cleared Traditional

PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS

K082959 · Unimed Medical Supplies, Inc. · Cardiovascular
Oct 2008
Decision
7d
Days
Class 2
Risk

About This 510(k) Submission

K082959 is an FDA 510(k) clearance for the PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by Unimed Medical Supplies, Inc. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on October 10, 2008, 7 days after receiving the submission on October 3, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K082959 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2008
Decision Date October 10, 2008
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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