NUCAMMA BI90— 510(k) K003882

Substantially Equivalent

Is2 Research, Inc.

FDA 510(k) clearance K003882 for NUCAMMA BI90, Substantially Equivalent on 2001-02-21. Applicant: Is2 Research, Inc.. Device class: 2.

Clearance details

Applicant: Is2 Research, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2000-12-15
Decision date: 2001-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nepean, Ontario, 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.