The following data is part of a premarket notification filed by Ib Lab Gmbh with the FDA for Koala.
Device ID | K192109 |
510k Number | K192109 |
Device Name: | KOALA |
Classification | System, Image Processing, Radiological |
Applicant | IB Lab GmbH Hietzinger Hauptstrasse 50/10 Vienna, AT 1130 |
Contact | Richard Ljuhar |
Correspondent | John J Smith Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-05 |
Decision Date | 2019-11-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
09120105730082 | K192109 | 000 |
09120105730471 | K192109 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KOALA 98040615 not registered Live/Pending |
Drake Holdings, Inc. 2023-06-13 |
KOALA 97640531 not registered Live/Pending |
Tacony Corporation 2022-10-20 |
KOALA 97636225 not registered Live/Pending |
Carbon Ceiling, LLC 2022-10-18 |
KOALA 97636195 not registered Live/Pending |
Carbon Ceiling, LLC 2022-10-18 |
KOALA 97424199 not registered Live/Pending |
Konfetti, Inc. 2022-05-23 |
KOALA 97375119 not registered Live/Pending |
Koala Optics, LLC 2022-04-21 |
KOALA 97330219 not registered Live/Pending |
ShipPromo, LLC 2022-03-25 |
KOALA 90394013 not registered Live/Pending |
Tru Fragrance & Beauty LLC 2020-12-18 |
KOALA 90294413 not registered Live/Pending |
BEAMING WHITE, LLC 2020-11-02 |
KOALA 90028416 not registered Live/Pending |
Yujing Qian 2020-06-30 |
KOALA 88985245 not registered Live/Pending |
KOALA SLEEP PTY. LTD. 2019-02-28 |
KOALA 88433313 not registered Live/Pending |
Fuzz Productions, LLC 2019-05-16 |