CoolTone
K-Number: K251378 · 2025-07-14
ApplicantZimmer Medizinsysteme GmbH
Decision Date2025-07-14
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
CoolTone is a medical device manufactured by Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2025-07-14 under approval number K251378. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CoolTone?
CoolTone is a medical device that received FDA 510(k) clearance on 2025-07-14. It is manufactured by Zimmer Medizinsysteme GmbH. The 510(k) number is K251378.
When was CoolTone approved by the FDA?
CoolTone received FDA 510(k) clearance on 2025-07-14, under approval number K251378.
What company makes CoolTone?
CoolTone is manufactured by Zimmer Medizinsysteme GmbH.
What is the FDA product code for CoolTone?
The FDA product code for CoolTone is NGX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.