Cleared Special

K071285 - DIGITAL PULSE OXIMETER, MODEL 7500 (FDA 510(k) Clearance)

K071285 · Nonin Medical, Inc. · Anesthesiology device

Jul 2007

Decision

66d

Days

Class 2

Risk

K071285 is an FDA 510(k) clearance for the DIGITAL PULSE OXIMETER, MODEL 7500. 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 July 12, 2007, 66 days after receiving the submission on May 7, 2007.

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

Submission Details

510(k) Number	K071285 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 07, 2007
Decision Date	July 12, 2007
Days to Decision	66 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF