Cleared Traditional

KELLER CARDIAC MONITOR MEDIL KMS870

K914576 · Keller Medical Specialties Products, Inc. · Cardiovascular
Dec 1991
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K914576 is an FDA 510(k) clearance for the KELLER CARDIAC MONITOR MEDIL KMS870, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Keller Medical Specialties Products, Inc. (Antioch, US). The FDA issued a Cleared decision on December 30, 1991, 76 days after receiving the submission on October 15, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K914576 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1991
Decision Date December 30, 1991
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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