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Rune Labs Tremor Transducer System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213519
510(k) Type
Traditional
Applicant
Rune Labs, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/2022
Days to Decision
219 days
Submission Type
Summary

Rune Labs Tremor Transducer System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213519
510(k) Type
Traditional
Applicant
Rune Labs, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/2022
Days to Decision
219 days
Submission Type
Summary