ELITE BIOFEEDBACK— 510(k) K942563

Name: FDA 510(k) clearance K942563
Creator: U.S. Food and Drug Administration
Published: 1995-06-06

Substantially Equivalent

Laborie Medical Technologies, Ltd.

FDA 510(k) clearance K942563 for ELITE BIOFEEDBACK, Substantially Equivalent on 1995-06-06. Applicant: Laborie Medical Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Laborie Medical Technologies, Ltd.
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 1994-05-31
Decision date: 1995-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Burlington, VT, US

Download summary PDF View on FDA.gov ↗

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