The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Siemens Sc9000/sc9015 Tcp02/c02 Module.
| Device ID | K980287 |
| 510k Number | K980287 |
| Device Name: | SIEMENS SC9000/SC9015 TCP02/C02 MODULE |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Jacqueline E Emery |
| Correspondent | Jacqueline E Emery SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-26 |
| Decision Date | 1998-08-12 |
| Summary: | summary |