FDA 510(k)

ANORECTAL MANOMETRY SUITE, MODEL 9032S0201

K-Number: K991389 · 1999-07-15

ApplicantMedtronic Functional Diagnostics A/S

Decision Date1999-07-15

Product CodeFFX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 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 1999-07-15 under 510(k) number K991389. 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 ANORECTAL MANOMETRY SUITE, MODEL 9032S0201?

ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 is a medical device that received FDA 510(k) clearance on 1999-07-15. The listed applicant is Medtronic Functional Diagnostics A/S. The 510(k) number is K991389.

When did ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 receive FDA 510(k) clearance?

ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 received FDA 510(k) clearance on 1999-07-15, under 510(k) number K991389.

Who is the listed applicant for ANORECTAL MANOMETRY SUITE, MODEL 9032S0201?

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 ANORECTAL MANOMETRY SUITE, MODEL 9032S0201?

The FDA product code for ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 is FFX.

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Other records listing Medtronic Functional Diagnostics A/S as applicant

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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.