The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Capnostream20p With Hifi C02 Monitoring.
| Device ID | K123690 |
| 510k Number | K123690 |
| Device Name: | CAPNOSTREAM20P WITH HIFI C02 MONITORING |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. HAR HOTZVIM INDUSTRIAL PARK Jerusalem, IL 91450 |
| Contact | Dalia Givony |
| Correspondent | Dalia Givony ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. 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 | 2012-12-03 |
| Decision Date | 2014-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521722941 | K123690 | 000 |
| 10884521722927 | K123690 | 000 |
| 10884521551398 | K123690 | 000 |
| 10884521771697 | K123690 | 000 |
| 10884521209213 | K123690 | 000 |
| 10884521771703 | K123690 | 000 |
| 10884521520875 | K123690 | 000 |
| 10884521660755 | K123690 | 000 |