The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Siemens Sc 9000 Etco2 Module.
| Device ID | K954632 |
| 510k Number | K954632 |
| Device Name: | SIEMENS SC 9000 ETCO2 MODULE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Thomas Connelly |
| Correspondent | Thomas Connelly SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-06 |
| Decision Date | 1996-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098008167 | K954632 | 000 |