CoolTone
FDA 510(k) clearance K192940 · decided 2019-11-15
Clearance details
- K-number
- K192940
- Device name
- CoolTone
- Applicant
- Zimmer Medizinsysteme GmbH
- Decision
- Substantially Equivalent
- Date received
- 2019-10-18
- Decision date
- 2019-11-15
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- NGX
- Device class
- 2
- Regulation number
- 890.5850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Neu-Ulm, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.