The following data is part of a premarket notification filed by Oridion Capnography, Inc. with the FDA for Capnostream20 Two Parameter Bedside Monitor & Capnostream10 One Parameter Bedside Monitor.
| Device ID | K060065 |
| 510k Number | K060065 |
| Device Name: | CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR |
| Classification | Oximeter |
| Applicant | ORIDION CAPNOGRAPHY, INC. HAR HOTZVIM SCI BASED IND PK POB 45025 Jerusalem, IL 91450 |
| Contact | Sanford Brown |
| Correspondent | Sanford Brown ORIDION CAPNOGRAPHY, INC. HAR HOTZVIM SCI BASED IND PK 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 | 2006-01-09 |
| Decision Date | 2006-05-04 |
| Summary: | summary |