The following data is part of a premarket notification filed by Or-nim Medical Ltd. with the FDA for Cerox.
Device ID | K150268 |
510k Number | K150268 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-04 |
Decision Date | 2015-11-06 |
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 |