Cleared Traditional

K091787 - MODEL 6000 TWO PARAMETER BEDSIDE MONITOR (FDA 510(k) Clearance)

K091787 · Ivy Biomedical Systems, Inc. · Anesthesiology device

Oct 2009

Decision

114d

Days

Class 2

Risk

K091787 is an FDA 510(k) clearance for the MODEL 6000 TWO PARAMETER BEDSIDE MONITOR. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on October 9, 2009, 114 days after receiving the submission on June 17, 2009.

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

Submission Details

510(k) Number	K091787 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 17, 2009
Decision Date	October 09, 2009
Days to Decision	114 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF