FETA SCAN 1000 OBSTETRICAL IMAGER— 510(k) K852439

Name: FDA 510(k) clearance K852439
Creator: U.S. Food and Drug Administration
Published: 1985-08-30

Substantially Equivalent

International Biomedics, Inc.

FDA 510(k) clearance K852439 for FETA SCAN 1000 OBSTETRICAL IMAGER, Substantially Equivalent on 1985-08-30. Applicant: International Biomedics, Inc.. Device class: 2.

Clearance details

Applicant: International Biomedics, Inc.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1985-06-10
Decision date: 1985-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mercer Island, WA, US

Download summary PDF View on FDA.gov ↗

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