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FDA 510(k)

MHLX7EC TRANSDUCER

K-Number: K040213 · 2004-09-22

ApplicantMicrohelix, Inc.
Decision Date2004-09-22
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MHLX7EC TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Microhelix, Inc.. It received FDA 510(k) clearance on 2004-09-22 under 510(k) number K040213. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MHLX7EC TRANSDUCER?

MHLX7EC TRANSDUCER is a medical device that received FDA 510(k) clearance on 2004-09-22. The listed applicant is Microhelix, Inc.. The 510(k) number is K040213.

When did MHLX7EC TRANSDUCER receive FDA 510(k) clearance?

MHLX7EC TRANSDUCER received FDA 510(k) clearance on 2004-09-22, under 510(k) number K040213.

Who is the listed applicant for MHLX7EC TRANSDUCER?

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

What is the FDA product code for MHLX7EC TRANSDUCER?

The FDA product code for MHLX7EC TRANSDUCER is ITX.

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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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