COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG— 510(k) K093223

Substantially Equivalent

Compumedics Limited

FDA 510(k) clearance K093223 for COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG, Substantially Equivalent on 2010-01-15. Applicant: Compumedics Limited.

Clearance details

Applicant: Compumedics Limited
Product code: Code GWQ
Advisory panel: Neurology
Date received: 2009-10-13
Decision date: 2010-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbotsford, Victoria, AU

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