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FDA 510(k)

MX-7000 MICROXEL

K-Number: K111831 · 2011-12-19

ApplicantBio-Med USA, Inc.
Decision Date2011-12-19
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MX-7000 MICROXEL is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med USA, Inc.. It received FDA 510(k) clearance on 2011-12-19 under 510(k) number K111831. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MX-7000 MICROXEL?

MX-7000 MICROXEL is a medical device that received FDA 510(k) clearance on 2011-12-19. The listed applicant is Bio-Med USA, Inc.. The 510(k) number is K111831.

When did MX-7000 MICROXEL receive FDA 510(k) clearance?

MX-7000 MICROXEL received FDA 510(k) clearance on 2011-12-19, under 510(k) number K111831.

Who is the listed applicant for MX-7000 MICROXEL?

The FDA 510(k) record lists Bio-Med USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MX-7000 MICROXEL?

The FDA product code for MX-7000 MICROXEL is ONG.

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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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