Cleared Traditional

KELLER PULSE OXIMETER - KMS 850

K895987 · Keller Medical Specialties Products, Inc. · Anesthesiology
Feb 1990
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K895987 is an FDA 510(k) clearance for the KELLER PULSE OXIMETER - KMS 850, a Oximeter (Class II — Special Controls, product code DQA), submitted by Keller Medical Specialties Products, Inc. (Antioch, US). The FDA issued a Cleared decision on February 22, 1990, 133 days after receiving the submission on October 12, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K895987 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1989
Decision Date February 22, 1990
Days to Decision 133 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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