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Focus TENS Therapy, Model PM710-M/-L

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183215
510(k) Type
Traditional
Applicant
Omron Healthcare, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/7/2019
Days to Decision
292 days
Submission Type
Summary

Focus TENS Therapy, Model PM710-M/-L

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183215
510(k) Type
Traditional
Applicant
Omron Healthcare, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/7/2019
Days to Decision
292 days
Submission Type
Summary