Cleared Traditional

K893221 - MODEL 8500 HAND HELD PULSE OXIMETER (FDA 510(k) Clearance)

K893221 · Nonin Medical, Inc. · Anesthesiology device

Feb 1990

Decision

307d

Days

Class 2

Risk

K893221 is an FDA 510(k) clearance for the MODEL 8500 HAND HELD PULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Nonin Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 28, 1990, 307 days after receiving the submission on April 27, 1989.

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

Submission Details

510(k) Number	K893221 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 27, 1989
Decision Date	February 28, 1990
Days to Decision	307 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—