The following data is part of a premarket notification filed by Oridion Capnography, Inc. with the FDA for Capnostream20 With Micromedico2 Module.
| Device ID | K094012 |
| 510k Number | K094012 |
| Device Name: | CAPNOSTREAM20 WITH MICROMEDICO2 MODULE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ORIDION CAPNOGRAPHY, INC. 160 GOULD STREET Needham, MA 02494 |
| Contact | Rachel Weissbrod |
| Correspondent | Rachel Weissbrod ORIDION CAPNOGRAPHY, INC. 160 GOULD STREET Needham, MA 02494 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-29 |
| Decision Date | 2010-05-12 |
| Summary: | summary |