Cleared Traditional

K012770 - INFINITY MICRO2+ (FDA 510(k) Clearance)

K012770 · Siemens Medical Solutions USA, Inc. · Anesthesiology device

Jul 2002

Decision

340d

Days

Class 2

Risk

K012770 is an FDA 510(k) clearance for the INFINITY MICRO2+. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on July 23, 2002, 340 days after receiving the submission on August 17, 2001.

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

Submission Details

510(k) Number	K012770 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 17, 2001
Decision Date	July 23, 2002
Days to Decision	340 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF