The following data is part of a premarket notification filed by Oridion Capnography, Inc. with the FDA for Capnostream 20 With A2 Adaptive Averaging Software.
| Device ID | K072295 |
| 510k Number | K072295 |
| Device Name: | CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE |
| Classification | Oximeter |
| Applicant | ORIDION CAPNOGRAPHY, INC. HAMARPE 7 Jerusalem, IL 91450 |
| Contact | Rachel Weissbrod |
| Correspondent | Rachel Weissbrod ORIDION CAPNOGRAPHY, INC. HAMARPE 7 Jerusalem, IL 91450 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-16 |
| Decision Date | 2007-10-11 |
| Summary: | summary |