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Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173042
510(k) Type
Traditional
Applicant
Edan Instruments, Inc
Country
China
FDA Decision
Substantially Equivalent
Decision Date
8/30/2018
Days to Decision
336 days
Submission Type
Summary

Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173042
510(k) Type
Traditional
Applicant
Edan Instruments, Inc
Country
China
FDA Decision
Substantially Equivalent
Decision Date
8/30/2018
Days to Decision
336 days
Submission Type
Summary