IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM— 510(k) K052577

Name: FDA 510(k) clearance K052577
Creator: U.S. Food and Drug Administration
Published: 2006-01-24

Substantially Equivalent

Ikonisys, Inc.

FDA 510(k) clearance K052577 for IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM, Substantially Equivalent on 2006-01-24. Applicant: Ikonisys, Inc.. Device class: 2.

Clearance details

Applicant: Ikonisys, Inc.
Product code: Code JOY
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 2005-09-19
Decision date: 2006-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Haven, CT, US

Download summary PDF View on FDA.gov ↗

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