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POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011472
510(k) Type
Traditional
Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
8/10/2001
Days to Decision
88 days
Submission Type
Summary

POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011472
510(k) Type
Traditional
Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
8/10/2001
Days to Decision
88 days
Submission Type
Summary