The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Modification To: Mac-line O2/co2 Oral Nasal Cannula Sample Line.
| Device ID | K013845 |
| 510k Number | K013845 |
| Device Name: | MODIFICATION TO: MAC-LINE O2/CO2 ORAL 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 | 2001-11-20 |
| Decision Date | 2001-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521552326 | K013845 | 000 |
| 10884521531598 | K013845 | 000 |
| 30884521551941 | K013845 | 000 |
| 20884521552156 | K013845 | 000 |
| 10884521520769 | K013845 | 000 |