Cleared Traditional

SATLITE PLUS PULSE OXIMETER

K905140 · Datex Division Instrumentarium Corp. · Anesthesiology
May 1991
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K905140 is an FDA 510(k) clearance for the SATLITE PLUS PULSE OXIMETER, a Oximeter (Class II — Special Controls, product code DQA), submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on May 28, 1991, 194 days after receiving the submission on November 15, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K905140 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1990
Decision Date May 28, 1991
Days to Decision 194 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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