Cleared Traditional

SIEMENS SC9000/SC9015 TCP02/C02 MODULE

K980287 · Siemens Medical Solutions USA, Inc. · Anesthesiology

Aug 1998

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K980287 is an FDA 510(k) clearance for the SIEMENS SC9000/SC9015 TCP02/C02 MODULE, a Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (Class II — Special Controls, product code KLK), submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on August 12, 1998, 198 days after receiving the submission on January 26, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2500.

Submission Details

510(k) Number	K980287 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 1998
Decision Date	August 12, 1998
Days to Decision	198 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.2500