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AcuPebble OX100

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222950
510(k) Type
Traditional
Applicant
Acurable Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
2/3/2023
Days to Decision
129 days
Submission Type
Summary

AcuPebble OX100

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222950
510(k) Type
Traditional
Applicant
Acurable Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
2/3/2023
Days to Decision
129 days
Submission Type
Summary