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HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163283
510(k) Type
Traditional
Applicant
HAMILTON MEDICAL AG
Country
Switzerland
FDA Decision
Substantially Equivalent
Decision Date
9/20/2017
Days to Decision
303 days
Submission Type
Summary

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163283
510(k) Type
Traditional
Applicant
HAMILTON MEDICAL AG
Country
Switzerland
FDA Decision
Substantially Equivalent
Decision Date
9/20/2017
Days to Decision
303 days
Submission Type
Summary