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FDA 510(k)

XP1100 RF

K-Number: K152731 · 2016-07-20

ApplicantBTL Industries, Inc.
Decision Date2016-07-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XP1100 RF is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2016-07-20 under approval number K152731. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XP1100 RF?

XP1100 RF is a medical device that received FDA 510(k) clearance on 2016-07-20. It is manufactured by BTL Industries, Inc.. The 510(k) number is K152731.

When was XP1100 RF approved by the FDA?

XP1100 RF received FDA 510(k) clearance on 2016-07-20, under approval number K152731.

What company makes XP1100 RF?

XP1100 RF is manufactured by BTL Industries, Inc..

What is the FDA product code for XP1100 RF?

The FDA product code for XP1100 RF is GEI.

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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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