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MODEL U-1000 WITH GESTATIONAL AGE CALCULATION

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K871385
510(k) Type
Traditional
Applicant
FUKUDA DENSHI USA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/26/1987
Days to Decision
49 days

MODEL U-1000 WITH GESTATIONAL AGE CALCULATION

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K871385
510(k) Type
Traditional
Applicant
FUKUDA DENSHI USA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/26/1987
Days to Decision
49 days