FDA 510(k)

ES-160

K-Number: K051020 · 2006-02-24

Decision Date2006-02-24

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ES-160 is the device name listed in this FDA 510(k) record. The listed applicant is Lhasa Oms, Inc.. It received FDA 510(k) clearance on 2006-02-24 under 510(k) number K051020. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ES-160?

ES-160 is a medical device that received FDA 510(k) clearance on 2006-02-24. The listed applicant is Lhasa Oms, Inc.. The 510(k) number is K051020.

When did ES-160 receive FDA 510(k) clearance?

ES-160 received FDA 510(k) clearance on 2006-02-24, under 510(k) number K051020.

Who is the listed applicant for ES-160?

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

What is the FDA product code for ES-160?

The FDA product code for ES-160 is GZJ.

Other records listing Lhasa Oms, Inc. as applicant

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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.