510(k) K980287
K980287 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "SIEMENS SC9000/SC9015 TCP02/C02 MODULE". The FDA issued a decision of Substantially Equivalent on August 12, 1998. The device falls under product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1998
- Date Received
- January 26, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.2500
- Review Panel
- AN
- Submission Type