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FDA 510(k)

BUTTERFLY TONER MODEL GYM070

K-Number: K093368 · 2010-01-27

ApplicantGlobal Marketing Partners Dba Gymmax USA
Decision Date2010-01-27
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BUTTERFLY TONER MODEL GYM070 is the device name listed in this FDA 510(k) record. The listed applicant is Global Marketing Partners Dba Gymmax USA. It received FDA 510(k) clearance on 2010-01-27 under 510(k) number K093368. 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 BUTTERFLY TONER MODEL GYM070?

BUTTERFLY TONER MODEL GYM070 is a medical device that received FDA 510(k) clearance on 2010-01-27. The listed applicant is Global Marketing Partners Dba Gymmax USA. The 510(k) number is K093368.

When did BUTTERFLY TONER MODEL GYM070 receive FDA 510(k) clearance?

BUTTERFLY TONER MODEL GYM070 received FDA 510(k) clearance on 2010-01-27, under 510(k) number K093368.

Who is the listed applicant for BUTTERFLY TONER MODEL GYM070?

The FDA 510(k) record lists Global Marketing Partners Dba Gymmax USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BUTTERFLY TONER MODEL GYM070?

The FDA product code for BUTTERFLY TONER MODEL GYM070 is NGX.

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Related Devices (Code: NGX)

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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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