The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Microstream Luer Adult-pediatric Intubated Sampling Line, Microstream Advance Adult-pediatric Intubated Filter Line.
| Device ID | K181467 |
| 510k Number | K181467 |
| Device Name: | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Oridion Medical 1987 Ltd. 7 Hamarpe Street P.O. Box 45025 Jerusalem, IL 9777407 |
| Contact | Dalia Givony |
| Correspondent | Dalia Givony Oridion Medical 1987 Ltd. 7 Hamarpe Street P.O. Box 45025 Jerusalem, IL 9777407 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-04 |
| Decision Date | 2019-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521762015 | K181467 | 000 |
| 20884838093670 | K181467 | 000 |
| 20884838093601 | K181467 | 000 |
| 20884838093564 | K181467 | 000 |
| 20884838093137 | K181467 | 000 |
| 20884838091867 | K181467 | 000 |
| 20884838091850 | K181467 | 000 |
| 20884838091836 | K181467 | 000 |
| 10884521771765 | K181467 | 000 |
| 10884521762275 | K181467 | 000 |
| 10884521762268 | K181467 | 000 |
| 20884838093809 | K181467 | 000 |
| 10884521761896 | K181467 | 000 |
| 10884521762145 | K181467 | 000 |
| 10884521762008 | K181467 | 000 |
| 10884521761995 | K181467 | 000 |
| 10884521761988 | K181467 | 000 |
| 10884521761933 | K181467 | 000 |
| 10884521761919 | K181467 | 000 |
| 10884521761902 | K181467 | 000 |
| 10884521761889 | K181467 | 000 |
| 10884521761957 | K181467 | 000 |
| 10884521761926 | K181467 | 000 |
| 10884521762169 | K181467 | 000 |
| 10884521762251 | K181467 | 000 |