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EchoGo Core (2.0)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213275
510(k) Type
Traditional
Applicant
Ultromics Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
12/20/2021
Days to Decision
81 days
Submission Type
Summary

EchoGo Core (2.0)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213275
510(k) Type
Traditional
Applicant
Ultromics Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
12/20/2021
Days to Decision
81 days
Submission Type
Summary