Cleared Traditional

K903702 - MODEL 90421 FLEXPORT INTERFACE
(FDA 510(k) Clearance)

Oct 1990
Decision
80d
Days
Class 2
Risk

K903702 is an FDA 510(k) clearance for the MODEL 90421 FLEXPORT INTERFACE. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on October 19, 1990, 80 days after receiving the submission on July 31, 1990.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K903702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date October 19, 1990
Days to Decision 80 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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