External upper limb tremor stimulator— 510(k) K182706
Substantially EquivalentCala Health, Inc.
FDA 510(k) clearance K182706 for External upper limb tremor stimulator, Substantially Equivalent on 2018-10-25. Applicant: Cala Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Cala Health, Inc.
- Product code
- Code QBC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5897
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Burlingame, CA, US
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