Cleared Traditional

K092727 - H100B PULSE OXIMETER (FDA 510(k) Clearance)

K092727 · Edan Instruments, Inc. · Anesthesiology device

Dec 2009

Decision

90d

Days

Class 2

Risk

K092727 is an FDA 510(k) clearance for the H100B PULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Edan Instruments, Inc. (Shanghai, CN). The FDA issued a Cleared decision on December 3, 2009, 90 days after receiving the submission on September 4, 2009.

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

Submission Details

510(k) Number	K092727 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 04, 2009
Decision Date	December 03, 2009
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF