Cleared Traditional

KELLER PULSE OXIMETER, MODEL 850+

K982331 · Keller Medical Specialties Products, Inc. · Anesthesiology
Sep 1998
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K982331 is an FDA 510(k) clearance for the KELLER PULSE OXIMETER, MODEL 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 September 11, 1998, 71 days after receiving the submission on July 2, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K982331 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1998
Decision Date September 11, 1998
Days to Decision 71 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

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

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