The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Capnostream20p With Ai/odi.
| Device ID | K112368 |
| 510k Number | K112368 |
| Device Name: | CAPNOSTREAM20P WITH AI/ODI |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ORIDION MEDICAL 1987 LTD. 7 HAMARPE STREET, HAR HOTZVIM INDUSTRIAL PARK Jerusalem, IL 91450 |
| Contact | Rachel Weissbrod |
| Correspondent | Rachel Weissbrod ORIDION MEDICAL 1987 LTD. 7 HAMARPE STREET, HAR HOTZVIM INDUSTRIAL PARK Jerusalem, IL 91450 |
| Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | MNR |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-17 |
| Decision Date | 2012-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521722941 | K112368 | 000 |
| 10884521807198 | K112368 | 000 |
| 10884521771710 | K112368 | 000 |