The following data is part of a premarket notification filed by Respcare Inc. with the FDA for Utopia.
Device ID | K052249 |
510k Number | K052249 |
Device Name: | UTOPIA |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | RESPCARE INC. 6601 LYONS ROAD, SUITES B1-B4 Coconut Creek, FL 33073 |
Contact | Frank Pelc |
Correspondent | Frank Pelc RESPCARE INC. 6601 LYONS ROAD, SUITES B1-B4 Coconut Creek, FL 33073 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-08-18 |
Decision Date | 2005-12-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10607411945707 | K052249 | 000 |
10607411945691 | K052249 | 000 |
10607411945684 | K052249 | 000 |
10607411945615 | K052249 | 000 |
10607411945608 | K052249 | 000 |
00607411945595 | K052249 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
UTOPIA 98734442 not registered Live/Pending |
R. Brown, Inc. 2024-09-05 |
UTOPIA 98636656 not registered Live/Pending |
Mastronardi Produce Limited 2024-07-08 |
UTOPIA 98476491 not registered Live/Pending |
MAHRAJ HOSSAIN 2024-03-30 |
UTOPIA 98459284 not registered Live/Pending |
Huntar Company Inc. 2024-03-20 |
UTOPIA 98289625 not registered Live/Pending |
Utopia Towels Inc. 2023-11-29 |
UTOPIA 98227354 not registered Live/Pending |
Utopia Worldwide, LLC 2023-10-17 |
UTOPIA 98148154 not registered Live/Pending |
Focal JMLAB 2023-08-24 |
UTOPIA 98110376 not registered Live/Pending |
LAFLAME ENTERPRISES, INC. 2023-07-31 |
UTOPIA 98098274 not registered Live/Pending |
Benjamin Esgro 2023-07-24 |
UTOPIA 98082473 not registered Live/Pending |
LAFLAME ENTERPRISES, INC. 2023-07-12 |
UTOPIA 98082471 not registered Live/Pending |
LAFLAME ENTERPRISES, INC. 2023-07-12 |
UTOPIA 97586924 not registered Live/Pending |
Utopia Towels Inc. 2022-09-12 |