FDA 510(k)

LITE-MED LM-9200 ELMA

K-Number: K103217 · 2011-09-28

Decision Date2011-09-28

Product CodeLNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

LITE-MED LM-9200 ELMA is the device name listed in this FDA 510(k) record. The listed applicant is Lite-Med, Inc.. It received FDA 510(k) clearance on 2011-09-28 under 510(k) number K103217. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITE-MED LM-9200 ELMA?

LITE-MED LM-9200 ELMA is a medical device that received FDA 510(k) clearance on 2011-09-28. The listed applicant is Lite-Med, Inc.. The 510(k) number is K103217.

When did LITE-MED LM-9200 ELMA receive FDA 510(k) clearance?

LITE-MED LM-9200 ELMA received FDA 510(k) clearance on 2011-09-28, under 510(k) number K103217.

Who is the listed applicant for LITE-MED LM-9200 ELMA?

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

What is the FDA product code for LITE-MED LM-9200 ELMA?

The FDA product code for LITE-MED LM-9200 ELMA is LNS.

Other records listing Lite-Med, Inc. 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.

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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.