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FDA 510(k)

AM-100

K-Number: K163165 · 2017-02-16

ApplicantBTL Industries, Inc.
Decision Date2017-02-16
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AM-100 is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2017-02-16 under approval number K163165. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AM-100?

AM-100 is a medical device that received FDA 510(k) clearance on 2017-02-16. It is manufactured by BTL Industries, Inc.. The 510(k) number is K163165.

When was AM-100 approved by the FDA?

AM-100 received FDA 510(k) clearance on 2017-02-16, under approval number K163165.

What company makes AM-100?

AM-100 is manufactured by BTL Industries, Inc..

What is the FDA product code for AM-100?

The FDA product code for AM-100 is NGX.

Other Devices by BTL Industries, Inc.

K162010HPM-6000U K160992HPM-6000 K161551TR-100 K152731XP1100 RF K163176Exilis XP II K180359BTL-FR2000

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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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