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External upper limb tremor stimulator

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182706
510(k) Type
Special
Applicant
Cala Health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/25/2018
Days to Decision
28 days
Submission Type
Summary

External upper limb tremor stimulator

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182706
510(k) Type
Special
Applicant
Cala Health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/25/2018
Days to Decision
28 days
Submission Type
Summary