K980287 is an FDA 510(k) clearance for the SIEMENS SC9000/SC9015 TCP02/C02 MODULE. This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.2500.
| 510(k) Number | K980287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2500 |