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 |