The following data is part of a premarket notification filed by Quantel Medical with the FDA for Absolu.
| Device ID | K183414 |
| 510k Number | K183414 |
| Device Name: | ABSOLU |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Quantel Medical 11 Rue Du Bois Joli-CS40015 Cournon D'auvergne-cedex, FR 63808 |
| Contact | Bruno Pages |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-10 |
| Decision Date | 2019-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700542625521 | K183414 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ABSOLU 90055906 not registered Live/Pending |
GGSUCCESS LLC 2020-07-16 |
![]() ABSOLU 81044834 1044834 Dead/Cancelled |
Francois; Claude 0000-00-00 |
![]() ABSOLU 79196167 5220492 Live/Registered |
QUANTEL MEDICAL 2016-07-18 |
![]() ABSOLU 76054851 not registered Dead/Abandoned |
RMC U.S.A. INC. 2000-05-03 |
![]() ABSOLU 75530124 2281423 Dead/Cancelled |
Ceres, LLC 1998-08-03 |
![]() ABSOLU 75182532 2163330 Dead/Cancelled |
Absolu Technologies Inc. 1996-10-16 |
![]() ABSOLU 74715803 2118736 Dead/Cancelled |
VALRHONA 1995-08-15 |