Cleared Traditional

K013319 - NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR (FDA 510(k) Clearance)

K013319 · Nonin Medical, Inc. · Anesthesiology device

Jan 2002

Decision

90d

Days

Class 2

Risk

K013319 is an FDA 510(k) clearance for the NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR. 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 January 3, 2002, 90 days after receiving the submission on October 5, 2001.

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

Submission Details

510(k) Number	K013319 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 05, 2001
Decision Date	January 03, 2002
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF