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FDA 510(k)

ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1

K-Number: K082056 · 2008-11-07

ApplicantLife-Tech, Inc.
Decision Date2008-11-07
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech, Inc.. It received FDA 510(k) clearance on 2008-11-07 under 510(k) number K082056. 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 SOFTWARE OPTION ARM-1?

ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Life-Tech, Inc.. The 510(k) number is K082056.

When did ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 receive FDA 510(k) clearance?

ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 received FDA 510(k) clearance on 2008-11-07, under 510(k) number K082056.

Who is the listed applicant for ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1?

The FDA 510(k) record lists Life-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1?

The FDA product code for ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 is FFX.

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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.

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