CoolTone— 510(k) K192940

Substantially Equivalent

Zimmer Medizinsysteme GmbH

FDA 510(k) clearance K192940 for CoolTone, Substantially Equivalent on 2019-11-15. Applicant: Zimmer Medizinsysteme GmbH.

Clearance details

Applicant: Zimmer Medizinsysteme GmbH
Product code: Code NGX
Advisory panel: Physical Medicine
Date received: 2019-10-18
Decision date: 2019-11-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Neu-Ulm, DE

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