STETHOS

Stethoscope, Electronic

THERATECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Theratechnologies, Inc. with the FDA for Stethos.

Pre-market Notification Details

• 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