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CARDIOFAX CE, MODEL PEA-1110K

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042827
510(k) Type
Traditional
Applicant
NIHON KOHDEN AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/6/2005
Days to Decision
86 days
Submission Type
Summary

CARDIOFAX CE, MODEL PEA-1110K

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042827
510(k) Type
Traditional
Applicant
NIHON KOHDEN AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/6/2005
Days to Decision
86 days
Submission Type
Summary