Cleared Traditional

KELLER VITAL SIGNS MONITOR - KMS-890

K910262 · Keller Medical Specialties Products, Inc. · Cardiovascular
Apr 1991
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K910262 is an FDA 510(k) clearance for the KELLER VITAL SIGNS MONITOR - KMS-890, a Alarm, Blood-pressure (Class II — Special Controls, product code DSJ), submitted by Keller Medical Specialties Products, Inc. (Antioch, US). The FDA issued a Cleared decision on April 1, 1991, 69 days after receiving the submission on January 22, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1100.

Submission Details

510(k) Number K910262 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1991
Decision Date April 01, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DSJ — Alarm, Blood-pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1100