The following data is part of a premarket notification filed by Odvi with the FDA for Stethoflux.
| Device ID | K060064 |
| 510k Number | K060064 |
| Device Name: | STETHOFLUX |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | ODVI 69 RUE DE PARIS Orsay, FR 91400 |
| Contact | Armelle Laprelle |
| Correspondent | Armelle Laprelle ODVI 69 RUE DE PARIS Orsay, FR 91400 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-09 |
| Decision Date | 2006-04-10 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STETHOFLUX 79006576 3042040 Dead/Cancelled |
BINDEFELD Hervé 2004-09-17 |