Cleared Special

K030973 - PICOSAT II SPO2 PULSE OXIMETRY MODULE (FDA 510(k) Clearance)

K030973 · Philips Medical Systems · Anesthesiology device

Jul 2003

Decision

117d

Days

Class 2

Risk

K030973 is an FDA 510(k) clearance for the PICOSAT II SPO2 PULSE OXIMETRY MODULE. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on July 23, 2003, 117 days after receiving the submission on March 28, 2003.

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

Submission Details

510(k) Number	K030973 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 28, 2003
Decision Date	July 23, 2003
Days to Decision	117 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF