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FDA 510(k)

ACMI DUR-HL LASER SYSTEMS

K-Number: K060752 · 2006-05-25

ApplicantAcmi Corporation
Decision Date2006-05-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACMI DUR-HL LASER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Acmi Corporation. It received FDA 510(k) clearance on 2006-05-25 under 510(k) number K060752. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACMI DUR-HL LASER SYSTEMS?

ACMI DUR-HL LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 2006-05-25. The listed applicant is Acmi Corporation. The 510(k) number is K060752.

When did ACMI DUR-HL LASER SYSTEMS receive FDA 510(k) clearance?

ACMI DUR-HL LASER SYSTEMS received FDA 510(k) clearance on 2006-05-25, under 510(k) number K060752.

Who is the listed applicant for ACMI DUR-HL LASER SYSTEMS?

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

What is the FDA product code for ACMI DUR-HL LASER SYSTEMS?

The FDA product code for ACMI DUR-HL LASER SYSTEMS is GEX. This falls under the Gastroenterology category.

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Other records listing Acmi Corporation as applicant

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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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