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FDA 510(k)

XP200

K-Number: K122966 · 2013-04-08

ApplicantBtl Industries, Ltd.
Decision Date2013-04-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XP200 is the device name listed in this FDA 510(k) record. The listed applicant is Btl Industries, Ltd.. It received FDA 510(k) clearance on 2013-04-08 under 510(k) number K122966. 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 XP200?

XP200 is a medical device that received FDA 510(k) clearance on 2013-04-08. The listed applicant is Btl Industries, Ltd.. The 510(k) number is K122966.

When did XP200 receive FDA 510(k) clearance?

XP200 received FDA 510(k) clearance on 2013-04-08, under 510(k) number K122966.

Who is the listed applicant for XP200?

The FDA 510(k) record lists Btl Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XP200?

The FDA product code for XP200 is GEI.

Other records listing Btl Industries, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K092191EXILIS, MODEL 5000

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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