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FDA 510(k)

ACURA-EX

K-Number: K946232 · 1995-06-30

ApplicantLustgarten Multi-Tech Intl.
Decision Date1995-06-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ACURA-EX is the device name listed in this FDA 510(k) record. The listed applicant is Lustgarten Multi-Tech Intl.. It received FDA 510(k) clearance on 1995-06-30 under 510(k) number K946232. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACURA-EX?

ACURA-EX is a medical device that received FDA 510(k) clearance on 1995-06-30. The listed applicant is Lustgarten Multi-Tech Intl.. The 510(k) number is K946232.

When did ACURA-EX receive FDA 510(k) clearance?

ACURA-EX received FDA 510(k) clearance on 1995-06-30, under 510(k) number K946232.

Who is the listed applicant for ACURA-EX?

The FDA 510(k) record lists Lustgarten Multi-Tech Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACURA-EX?

The FDA product code for ACURA-EX is ESD.

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Related Devices (Code: ESD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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