The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for O2/co2 Nasal Filterline.
| Device ID | K010024 |
| 510k Number | K010024 |
| Device Name: | O2/CO2 NASAL FILTERLINE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O. BOX 45025 HAR HOTZVIM INDUSTRIAL PARK Jerusalem, IL 91450 |
| Contact | Sanford Brown |
| Correspondent | Sanford Brown ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O. BOX 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 | 2001-01-03 |
| Decision Date | 2001-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838071470 | K010024 | 000 |
| 10884521554016 | K010024 | 000 |
| 10884521551794 | K010024 | 000 |
| 10884521554047 | K010024 | 000 |
| 10884521554054 | K010024 | 000 |
| 10884521591738 | K010024 | 000 |
| 10884521554108 | K010024 | 000 |
| 20884521552071 | K010024 | 000 |
| 10884521552425 | K010024 | 000 |
| 20884838071098 | K010024 | 000 |
| 20884838071111 | K010024 | 000 |
| 20884838071128 | K010024 | 000 |
| 20884838071135 | K010024 | 000 |
| 20884838071142 | K010024 | 000 |
| 20884838071241 | K010024 | 000 |
| 10884521554009 | K010024 | 000 |