The following data is part of a premarket notification filed by Oridion Capnography, Inc. with the FDA for Capnostream20 With Integrated Pulmonary Index.
| Device ID | K082268 |
| 510k Number | K082268 |
| Device Name: | CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX |
| Classification | Oximeter |
| Applicant | ORIDION CAPNOGRAPHY, INC. HAR HOTZVIM SCIENCE PARK POB 45025 Jerusalem, IL 91450 |
| Contact | Rachel Weissbrod |
| Correspondent | Rachel Weissbrod ORIDION CAPNOGRAPHY, INC. HAR HOTZVIM SCIENCE PARK POB 45025 Jerusalem, IL 91450 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-11 |
| Decision Date | 2009-02-06 |
| Summary: | summary |