Cleared Traditional

K940463 - NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS (FDA 510(k) Clearance)

K940463 · Nonin Medical, Inc. · Anesthesiology device

Mar 1994

Decision

40d

Days

Class 2

Risk

K940463 is an FDA 510(k) clearance for the NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS. 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 March 14, 1994, 40 days after receiving the submission on February 2, 1994.

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

Submission Details

510(k) Number	K940463 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 02, 1994
Decision Date	March 14, 1994
Days to Decision	40 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement