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FDA 510(k)

EM-9000

K-Number: K101482 · 2011-03-31

ApplicantElite Medical, Inc.
Decision Date2011-03-31
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EM-9000 is the device name listed in this FDA 510(k) record. The listed applicant is Elite Medical, Inc.. It received FDA 510(k) clearance on 2011-03-31 under 510(k) number K101482. 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 EM-9000?

EM-9000 is a medical device that received FDA 510(k) clearance on 2011-03-31. The listed applicant is Elite Medical, Inc.. The 510(k) number is K101482.

When did EM-9000 receive FDA 510(k) clearance?

EM-9000 received FDA 510(k) clearance on 2011-03-31, under 510(k) number K101482.

Who is the listed applicant for EM-9000?

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

What is the FDA product code for EM-9000?

The FDA product code for EM-9000 is LNS.

Related Devices (Code: LNS)

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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