The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Mac-line 02/co2 Nasal Cannula Sample Line.
| Device ID | K012395 |
| 510k Number | K012395 |
| Device Name: | MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-27 |
| Decision Date | 2001-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521552203 | K012395 | 000 |
| 10884521640535 | K012395 | 000 |
| 20884521551753 | K012395 | 000 |