The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Smart Capnoline Guardian.
| Device ID | K093388 |
| 510k Number | K093388 |
| Device Name: | SMART CAPNOLINE GUARDIAN |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O.B. 45025 HAR HOTZVIM INDUSTRIAL PARK Jerusalem, IL 91450 |
| Contact | Rachel Weissbrod |
| Correspondent | Rachel Weissbrod ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O.B. 45025 HAR HOTZVIM INDUSTRIAL PARK Jerusalem, IL 91450 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-30 |
| Decision Date | 2010-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40884521520746 | K093388 | 000 |
| 20884838093748 | K093388 | 000 |
| 20884838091829 | K093388 | 000 |
| 30884521552146 | K093388 | 000 |
| 10884521554153 | K093388 | 000 |
| 10884521554146 | K093388 | 000 |
| 30884521552115 | K093388 | 000 |
| 20884521554136 | K093388 | 000 |
| 10884521520745 | K093388 | 000 |
| 20884838093755 | K093388 | 000 |
| 10884521531550 | K093388 | 000 |
| 20884838071296 | K093388 | 000 |
| 20884838071289 | K093388 | 000 |
| 20884838071272 | K093388 | 000 |
| 20884838071265 | K093388 | 000 |
| 20884838071258 | K093388 | 000 |
| 20884521552361 | K093388 | 000 |
| 10884521552333 | K093388 | 000 |
| 10884521552241 | K093388 | 000 |
| 10884521554160 | K093388 | 000 |