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BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011471
510(k) Type
Traditional
Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
11/8/2002
Days to Decision
543 days
Submission Type
Summary

BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011471
510(k) Type
Traditional
Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
11/8/2002
Days to Decision
543 days
Submission Type
Summary