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IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080825
510(k) Type
Traditional
Applicant
IMPEDIMED PTY LTD.
Country
Australia
FDA Decision
Substantially Equivalent - Kit
Decision Date
10/3/2008
Days to Decision
193 days
Submission Type
Summary

IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080825
510(k) Type
Traditional
Applicant
IMPEDIMED PTY LTD.
Country
Australia
FDA Decision
Substantially Equivalent - Kit
Decision Date
10/3/2008
Days to Decision
193 days
Submission Type
Summary