The following data is part of a premarket notification filed by Clew Medical Ltd. with the FDA for Clewicu System (clewicuserver And Clewicunitor).
| Device ID | K200717 |
| 510k Number | K200717 |
| Device Name: | CLEWICU System (ClewICUServer And ClewICUnitor) |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | CLEW Medical Ltd. 5 Hamelacha St. Netanya, IL 4206002 |
| Contact | Avigdor Faians |
| Correspondent | Yarmela Pavlovic Manatt, Phelps & Phillips, LLP 1 Embarcadero Center, 30th Floor San Francisco, CA 94111 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-18 |
| Decision Date | 2021-01-09 |