The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Microstream Oral Nasal Cannula Filterline.
| Device ID | K011050 |
| 510k Number | K011050 |
| Device Name: | MICROSTREAM ORAL NASAL CANNULA 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-06 |
| Decision Date | 2001-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838071418 | K011050 | 000 |
| 10884521531604 | K011050 | 000 |
| 20884521591698 | K011050 | 000 |
| 20884521554068 | K011050 | 000 |
| 10884521554078 | K011050 | 000 |
| 10884521551893 | K011050 | 000 |
| 20884521551739 | K011050 | 000 |
| 10884521531666 | K011050 | 000 |