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FETAL MONITOR MODEL: BT-200T

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100885
510(k) Type
Traditional
Applicant
BISTOS CO., LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/7/2010
Days to Decision
69 days
Submission Type
Summary

FETAL MONITOR MODEL: BT-200T

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100885
510(k) Type
Traditional
Applicant
BISTOS CO., LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/7/2010
Days to Decision
69 days
Submission Type
Summary