The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Capnography Extension, Intellivue Microstream Extension.
| Device ID | K172904 |
| 510k Number | K172904 |
| Device Name: | IntelliVue Capnography Extension, IntelliVue Microstream Extension |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str.-2 Boeblingen, DE 71034 |
| Contact | Markus Stacha |
| Correspondent | Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str.-2 Boeblingen, DE 71034 |
| Product Code | CCK |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | DRQ |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DXG |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-22 |
| Decision Date | 2017-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838083585 | K172904 | 000 |
| 00884838083578 | K172904 | 000 |