The following data is part of a premarket notification filed by Or-nim Medical Ltd. with the FDA for Cerox Model 3210.
| Device ID | K093923 |
| 510k Number | K093923 |
| Device Name: | CEROX MODEL 3210 |
| Classification | Oximeter, Tissue Saturation |
| Applicant | OR-NIM MEDICAL LTD. 1 YODFAT ST Lod, IL 71291 |
| Contact | Michal Balberg, Phd |
| Correspondent | Michal Balberg, Phd OR-NIM MEDICAL LTD. 1 YODFAT ST Lod, IL 71291 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-01-19 |
| Summary: | summary |