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FDA 510(k)

ANORECTAL MANOMETRY ANALYSIS MODULE

K-Number: K972439 · 1997-09-23

ApplicantMedtronic-Synectics
Decision Date1997-09-23
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANORECTAL MANOMETRY ANALYSIS MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic-Synectics. It received FDA 510(k) clearance on 1997-09-23 under 510(k) number K972439. 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 ANALYSIS MODULE?

ANORECTAL MANOMETRY ANALYSIS MODULE is a medical device that received FDA 510(k) clearance on 1997-09-23. The listed applicant is Medtronic-Synectics. The 510(k) number is K972439.

When did ANORECTAL MANOMETRY ANALYSIS MODULE receive FDA 510(k) clearance?

ANORECTAL MANOMETRY ANALYSIS MODULE received FDA 510(k) clearance on 1997-09-23, under 510(k) number K972439.

Who is the listed applicant for ANORECTAL MANOMETRY ANALYSIS MODULE?

The FDA 510(k) record lists Medtronic-Synectics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANORECTAL MANOMETRY ANALYSIS MODULE?

The FDA product code for ANORECTAL MANOMETRY ANALYSIS MODULE is FFX.

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Official Source

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

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