Cleared Traditional

K945290 - 8500A PULSE OXIMETER (FDA 510(k) Clearance)

K945290 · Nonin Medical, Inc. · Anesthesiology device

Feb 1997

Decision

834d

Days

Class 2

Risk

K945290 is an FDA 510(k) clearance for the 8500A PULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on February 11, 1997, 834 days after receiving the submission on October 31, 1994.

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

Submission Details

510(k) Number	K945290 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 31, 1994
Decision Date	February 11, 1997
Days to Decision	834 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement