CoolTone— 510(k) K251378
Substantially EquivalentZimmer Medizinsysteme GmbH
FDA 510(k) clearance K251378 for CoolTone, Substantially Equivalent on 2025-07-14. Applicant: Zimmer Medizinsysteme GmbH. Device class: 2.
Clearance details
- Applicant
- Zimmer Medizinsysteme GmbH
- Product code
- Code NGX
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Neu-Elm, DE
Recent devices under product code NGX
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