The following data is part of a premarket notification filed by Or-nim Medical Ltd. with the FDA for Cerox.
| Device ID | K131854 |
| 510k Number | K131854 |
| Device Name: | CEROX |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | OR-NIM MEDICAL LTD. 15 ATIR YEDA ST. Kfar Saba, IL 4464312 |
| Contact | Micha Oestereich |
| Correspondent | Micha Oestereich OR-NIM MEDICAL LTD. 15 ATIR YEDA ST. Kfar Saba, IL 4464312 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-21 |
| Decision Date | 2013-09-13 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CEROX 75630134 2311796 Dead/Cancelled |
CerOx Corporation 1999-01-28 |
![]() CEROX 75160415 not registered Dead/Abandoned |
Moltech Invent S.A. 1996-09-04 |
![]() CEROX 75160292 not registered Dead/Abandoned |
Moltech Invent S.A. 1996-09-04 |
![]() CEROX 75160291 not registered Dead/Abandoned |
Moltech Invent S.A. 1996-09-04 |
![]() CEROX 75160201 not registered Dead/Abandoned |
Moltech Invent S.A. 1996-09-04 |
![]() CEROX 73105199 1214559 Live/Registered |
Rhodia, Inc. 1976-11-02 |
![]() CEROX 72165735 0778942 Live/Registered |
BABCOCK & WILCOX COMPANY, THE 1963-04-01 |
![]() CEROX 71612619 0567685 Dead/Expired |
LINDSAY LIGHT & CHEMICAL COMPANY 1951-04-13 |