The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Comfit.
| Device ID | K834089 |
| 510k Number | K834089 |
| Device Name: | COMFIT |
| Classification | Support, Breathing Tube |
| Applicant | ACKRAD LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JAY |
| CFR Regulation Number | 868.5280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-28 |
| Decision Date | 1983-12-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COMFIT 90506008 not registered Live/Pending |
Zhang Wei 2021-02-02 |
![]() COMFIT 86517896 4906133 Live/Registered |
Klein Electronics, Inc. 2015-01-29 |
![]() COMFIT 86468134 4785051 Live/Registered |
Gelmart Industries, Inc. 2014-12-01 |
![]() COMFIT 79234885 5592716 Live/Registered |
TOSHIBA MITSUBISHI-ELECTRIC INDUSTRIALSYSTEMS CORPORATION 2018-01-31 |
![]() COMFIT 78532841 not registered Dead/Abandoned |
Omron Healthcare, Inc. 2004-12-15 |
![]() COMFIT 77069292 not registered Dead/Abandoned |
Whistleblower Limited 2006-12-21 |
![]() COMFIT 75523430 not registered Dead/Abandoned |
ISACO INTERNATIONAL CORPORATION 1998-07-22 |
![]() COMFIT 74715441 2116672 Dead/Cancelled |
New Balance Athletic Shoe, Inc. 1995-08-14 |
![]() COMFIT 74430895 1900514 Dead/Cancelled |
WRP ASIA PACIFIC SDN BHD 1993-08-27 |
![]() COMFIT 74149265 not registered Dead/Abandoned |
C. & J. CLARK AMERICA, INC. 1991-03-19 |
![]() COMFIT 73152819 1108422 Dead/Expired |
UNITIKA LTD. 1977-12-20 |
![]() COMFIT 71113972 0125458 Dead/Expired |
KNOX HAT COMPANY, INC. 1918-10-31 |