The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Capnostream 35 Portable Respiratory Monitor.
| Device ID | K200594 |
| 510k Number | K200594 |
| Device Name: | Capnostream 35 Portable Respiratory Monitor |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Oridion Medical 1987 Ltd. 7 Hamarpe St. Jerusalem, IL 9777407 |
| Contact | Lital David |
| Correspondent | Jonathan Kahan Hogan Lovells US LLP 555 13th St. NW Washington, Dc, DC 20004 |
| Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | MNR |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-06 |
| Decision Date | 2020-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521761216 | K200594 | 000 |