STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX— 510(k) K001306

Substantially Equivalent

Andromed, Inc.

FDA 510(k) clearance K001306 for STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX, Substantially Equivalent on 2000-07-20. Applicant: Andromed, Inc.. Device class: 2.

Clearance details

Applicant: Andromed, Inc.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2000-04-25
Decision date: 2000-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Laurent, Quebec, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.