BREAST THERMAL ACTIVITY INDICATOR— 510(k) K832989

Name: FDA 510(k) clearance K832989
Creator: U.S. Food and Drug Administration
Published: 1984-01-17

Substantially Equivalent

Bcsi Laboratories, Inc.

FDA 510(k) clearance K832989 for BREAST THERMAL ACTIVITY INDICATOR, Substantially Equivalent on 1984-01-17. Applicant: Bcsi Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Bcsi Laboratories, Inc.
Product code: Code KYA
Device class: Class 1
Regulation: 21 CFR 884.2982
Advisory panel: Obstetrics/Gynecology
Date received: 1983-09-01
Decision date: 1984-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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