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IMPEDIMED - EXTRACELLULAR FLUID ANALYZER 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
K100811
510(k) Type
Traditional
Applicant
IMPEDIMED LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/4/2011
Days to Decision
592 days
Submission Type
Summary

IMPEDIMED - EXTRACELLULAR FLUID ANALYZER 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
K100811
510(k) Type
Traditional
Applicant
IMPEDIMED LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/4/2011
Days to Decision
592 days
Submission Type
Summary