The following data is part of a premarket notification filed by Oridion Medical Ltd. with the FDA for Microstream Filterline Icu.
| Device ID | K980327 |
| 510k Number | K980327 |
| Device Name: | MICROSTREAM FILTERLINE ICU |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ORIDION MEDICAL LTD. P.O. BOX 45025 Jerusalem, IL 91450 |
| Contact | Sanford Brown |
| Correspondent | Sanford Brown ORIDION MEDICAL LTD. P.O. BOX 45025 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 | 1998-01-28 |
| Decision Date | 1998-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838071357 | K980327 | 000 |
| 10884521640559 | K980327 | 000 |
| 20884838071173 | K980327 | 000 |
| 30884521216017 | K980327 | 000 |
| 10884521551992 | K980327 | 000 |
| 10884521552227 | K980327 | 000 |
| 10884521552296 | K980327 | 000 |
| 10884521552388 | K980327 | 000 |
| 10884521552395 | K980327 | 000 |
| 10884521552418 | K980327 | 000 |
| 20884838071166 | K980327 | 000 |
| 20884838071180 | K980327 | 000 |
| 20884838071326 | K980327 | 000 |
| 20884521551784 | K980327 | 000 |