The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Microstream Advance Neonatal-infant Nasal Filter Line With O2 Tubing, Microstream Advance Pediatric Oral-nasal Filter Line With O2 Tubing, Microstream Advance Adult Oral-nasal Filter Line With O2 Tubing, Microstream Luer Adult Oral-nasal Sampling Lin.
| Device ID | K181624 |
| 510k Number | K181624 |
| Device Name: | Microstream Advance Neonatal-Infant Nasal Filter Line With O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line With O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line With O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Lin |
| 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 | 2018-06-20 |
| Decision Date | 2019-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838093908 | K181624 | 000 |
| 20884838093700 | K181624 | 000 |
| 20884838093694 | K181624 | 000 |
| 20884838093687 | K181624 | 000 |
| 20884838091928 | K181624 | 000 |
| 20884838091911 | K181624 | 000 |
| 20884838091904 | K181624 | 000 |
| 20884838091898 | K181624 | 000 |
| 20884838091881 | K181624 | 000 |
| 20884838091874 | K181624 | 000 |
| 20884838093717 | K181624 | 000 |
| 20884838093724 | K181624 | 000 |
| 20884838093731 | K181624 | 000 |
| 20884838093892 | K181624 | 000 |
| 20884838093885 | K181624 | 000 |
| 20884838093878 | K181624 | 000 |
| 20884838093861 | K181624 | 000 |
| 20884838093830 | K181624 | 000 |
| 20884838093823 | K181624 | 000 |
| 20884838093816 | K181624 | 000 |
| 20884838093793 | K181624 | 000 |
| 20884838093762 | K181624 | 000 |
| 20884838091782 | K181624 | 000 |