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FDA 510(k)

PIVOT ASSIST

K-Number: K081053 · 2008-10-09

ApplicantPivot Assist, LLC
Decision Date2008-10-09
Product CodeINO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PIVOT ASSIST is the device name listed in this FDA 510(k) record. The listed applicant is Pivot Assist, LLC. It received FDA 510(k) clearance on 2008-10-09 under 510(k) number K081053. The device is classified under product code INO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIVOT ASSIST?

PIVOT ASSIST is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Pivot Assist, LLC. The 510(k) number is K081053.

When did PIVOT ASSIST receive FDA 510(k) clearance?

PIVOT ASSIST received FDA 510(k) clearance on 2008-10-09, under 510(k) number K081053.

Who is the listed applicant for PIVOT ASSIST?

The FDA 510(k) record lists Pivot Assist, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIVOT ASSIST?

The FDA product code for PIVOT ASSIST is INO.

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Related Devices (Code: INO)

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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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