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FDA 510(k)

HM-LAMP II

K-Number: K100234 · 2010-07-08

ApplicantHillusa, Inc.
Decision Date2010-07-08
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HM-LAMP II is the device name listed in this FDA 510(k) record. The listed applicant is Hillusa, Inc.. It received FDA 510(k) clearance on 2010-07-08 under 510(k) number K100234. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HM-LAMP II?

HM-LAMP II is a medical device that received FDA 510(k) clearance on 2010-07-08. The listed applicant is Hillusa, Inc.. The 510(k) number is K100234.

When did HM-LAMP II receive FDA 510(k) clearance?

HM-LAMP II received FDA 510(k) clearance on 2010-07-08, under 510(k) number K100234.

Who is the listed applicant for HM-LAMP II?

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

What is the FDA product code for HM-LAMP II?

The FDA product code for HM-LAMP II is FTD.

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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

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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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