5000Z FIREFLY SYSTEM— 510(k) K133502

Substantially Equivalent

Prizm Medical, Inc.

FDA 510(k) clearance K133502 for 5000Z FIREFLY SYSTEM, Substantially Equivalent on 2014-12-03. Applicant: Prizm Medical, Inc..

Clearance details

Applicant: Prizm Medical, Inc.
Product code: Code NUH
Advisory panel: Neurology
Date received: 2013-11-14
Decision date: 2014-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

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