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FDA 510(k)

LEVINIUM

K-Number: K884257 · 1988-12-22

ApplicantTicomet Engineering & Consulting
Decision Date1988-12-22
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEVINIUM is the device name listed in this FDA 510(k) record. The listed applicant is Ticomet Engineering & Consulting. It received FDA 510(k) clearance on 1988-12-22 under 510(k) number K884257. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEVINIUM?

LEVINIUM is a medical device that received FDA 510(k) clearance on 1988-12-22. The listed applicant is Ticomet Engineering & Consulting. The 510(k) number is K884257.

When did LEVINIUM receive FDA 510(k) clearance?

LEVINIUM received FDA 510(k) clearance on 1988-12-22, under 510(k) number K884257.

Who is the listed applicant for LEVINIUM?

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

What is the FDA product code for LEVINIUM?

The FDA product code for LEVINIUM is EJH.

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Related Devices (Code: EJH)

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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