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 |