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FDA 510(k)

LONG LIFE PADTM

K-Number: K120516 · 2012-05-17

ApplicantOmron Healthcare, Inc.
Decision Date2012-05-17
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LONG LIFE PADTM is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2012-05-17 under 510(k) number K120516. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LONG LIFE PADTM?

LONG LIFE PADTM is a medical device that received FDA 510(k) clearance on 2012-05-17. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K120516.

When did LONG LIFE PADTM receive FDA 510(k) clearance?

LONG LIFE PADTM received FDA 510(k) clearance on 2012-05-17, under 510(k) number K120516.

Who is the listed applicant for LONG LIFE PADTM?

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

What is the FDA product code for LONG LIFE PADTM?

The FDA product code for LONG LIFE PADTM is GXY.

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Related Devices (Code: GXY)

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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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