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FDA 510(k)

LOKKI DT

K-Number: K952682 · 1995-11-14

ApplicantLokki
Decision Date1995-11-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LOKKI DT is the device name listed in this FDA 510(k) record. The listed applicant is Lokki. It received FDA 510(k) clearance on 1995-11-14 under 510(k) number K952682. 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 LOKKI DT?

LOKKI DT is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Lokki. The 510(k) number is K952682.

When did LOKKI DT receive FDA 510(k) clearance?

LOKKI DT received FDA 510(k) clearance on 1995-11-14, under 510(k) number K952682.

Who is the listed applicant for LOKKI DT?

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

What is the FDA product code for LOKKI DT?

The FDA product code for LOKKI DT is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Lokki as applicant

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.

K994028FLIPO XENON CURING LIGHT

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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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