The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Microstream O2/co2 Oral Nasal Filterline.
| Device ID | K011536 |
| 510k Number | K011536 |
| Device Name: | MICROSTREAM O2/CO2 ORAL 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-18 |
| Decision Date | 2001-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838071395 | K011536 | 000 |
| 30884521551903 | K011536 | 000 |
| 10884521591721 | K011536 | 000 |
| 10884521531635 | K011536 | 000 |
| 10884521531628 | K011536 | 000 |
| 10884521531567 | K011536 | 000 |
| 10884521593312 | K011536 | 000 |
| 10884521593305 | K011536 | 000 |
| 20884521552408 | K011536 | 000 |
| 20884521552064 | K011536 | 000 |
| 20884521552002 | K011536 | 000 |
| 20884521551807 | K011536 | 000 |
| 10884521551916 | K011536 | 000 |
| 10884521552302 | K011536 | 000 |
| 20884838071227 | K011536 | 000 |
| 20884838071210 | K011536 | 000 |
| 20884838071203 | K011536 | 000 |
| 20884838071197 | K011536 | 000 |
| 20884838071081 | K011536 | 000 |
| 20884838071074 | K011536 | 000 |
| 20884838071067 | K011536 | 000 |
| 20884838071050 | K011536 | 000 |
| 10884521592469 | K011536 | 000 |
| 20884521552378 | K011536 | 000 |
| 10884521552319 | K011536 | 000 |
| 20884521551746 | K011536 | 000 |