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FDA 510(k)

IR PRO 250

K-Number: K061080 · 2006-06-14

ApplicantLhasa Oms, Inc.
Decision Date2006-06-14
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IR PRO 250 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 2006-06-14 under 510(k) number K061080. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IR PRO 250?

IR PRO 250 is a medical device that received FDA 510(k) clearance on 2006-06-14. The listed applicant is Lhasa Oms, Inc.. The 510(k) number is K061080.

When did IR PRO 250 receive FDA 510(k) clearance?

IR PRO 250 received FDA 510(k) clearance on 2006-06-14, under 510(k) number K061080.

Who is the listed applicant for IR PRO 250?

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 IR PRO 250?

The FDA product code for IR PRO 250 is ILY.

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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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