The following data is part of a premarket notification filed by Theratechnologies, Inc. with the FDA for Stethos.
Device ID | K963621 |
510k Number | K963621 |
Device Name: | STETHOS |
Classification | Stethoscope, Electronic |
Applicant | THERATECHNOLOGIES, INC. 7701, 17TH AVENUE Montreal, Quebec, CA H2a 2s5 |
Contact | Michel Guerette |
Correspondent | Michel Guerette THERATECHNOLOGIES, INC. 7701, 17TH AVENUE Montreal, Quebec, CA H2a 2s5 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-06 |
Decision Date | 1996-12-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() STETHOS 98677010 not registered Live/Pending |
Stethos LLC 2024-07-31 |
![]() STETHOS 98676996 not registered Live/Pending |
Stethos LLC 2024-07-31 |
![]() STETHOS 86318825 5607308 Live/Registered |
Habboushe, Joseph 2014-06-24 |
![]() STETHOS 75354322 2294960 Dead/Cancelled |
MASIMO CORPORATION 1997-09-09 |