The following data is part of a premarket notification filed by Vectura Gmbh with the FDA for Fox Mobile.
Device ID | K142059 |
510k Number | K142059 |
Device Name: | FOX MOBILE |
Classification | Nebulizer (direct Patient Interface) |
Applicant | VECTURA GMBH ROBERT-KOCH-ALLEE 29 Gauting, DE 82131 |
Contact | Paul Dryden |
Correspondent | Paul Dryden VECTURA GMBH ROBERT-KOCH-ALLEE 29 Gauting, DE 82131 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-29 |
Decision Date | 2015-01-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05056143200055 | K142059 | 000 |
05056143200031 | K142059 | 000 |
05056143200024 | K142059 | 000 |
05056143200017 | K142059 | 000 |
05056143200000 | K142059 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FOX MOBILE 85665262 not registered Dead/Abandoned |
Twentieth Century Fox Film Corporation 2012-06-29 |
FOX MOBILE 77514098 3649839 Dead/Cancelled |
Twentieth Century Fox Film Corporation 2008-07-02 |
FOX MOBILE 77514088 not registered Dead/Abandoned |
Twentieth Century Fox Film Corporation 2008-07-02 |
FOX MOBILE 77356379 not registered Dead/Abandoned |
Twentieth Century Fox Film Corporation 2007-12-19 |
FOX MOBILE 77356378 not registered Dead/Abandoned |
Twentieth Century Fox Film Corporation 2007-12-19 |