Healy— 510(k) K191075
Substantially EquivalentTimewaver Production GmbH
FDA 510(k) clearance K191075 for Healy, Substantially Equivalent on 2019-11-22. Applicant: Timewaver Production GmbH. Device class: 2.
Clearance details
- Applicant
- Timewaver Production GmbH
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kranzlin, DE
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