FDA 510(k)

POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103

K-Number: K010130 · 2001-02-07

ApplicantMedtronic Functional Diagnostics A/S

Decision Date2001-02-07

Product CodeFFX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Functional Diagnostics A/S. It received FDA 510(k) clearance on 2001-02-07 under 510(k) number K010130. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103?

POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 is a medical device that received FDA 510(k) clearance on 2001-02-07. The listed applicant is Medtronic Functional Diagnostics A/S. The 510(k) number is K010130.

When did POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 receive FDA 510(k) clearance?

POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 received FDA 510(k) clearance on 2001-02-07, under 510(k) number K010130.

Who is the listed applicant for POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103?

The FDA 510(k) record lists Medtronic Functional Diagnostics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103?

The FDA product code for POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 is FFX.

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Other records listing Medtronic Functional Diagnostics A/S as applicant

K014269POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 K011471BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER K002992DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 K011472POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID K000386POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.