FDA 510(k)

LEP2000 THERAPY SYSTEM

K-Number: K073689 · 2008-11-13

ApplicantInternational Medical Instruments, Inc.

Decision Date2008-11-13

Product CodeNHN

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

LEP2000 THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Instruments, Inc.. It received FDA 510(k) clearance on 2008-11-13 under 510(k) number K073689. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEP2000 THERAPY SYSTEM?

LEP2000 THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-11-13. The listed applicant is International Medical Instruments, Inc.. The 510(k) number is K073689.

When did LEP2000 THERAPY SYSTEM receive FDA 510(k) clearance?

LEP2000 THERAPY SYSTEM received FDA 510(k) clearance on 2008-11-13, under 510(k) number K073689.

Who is the listed applicant for LEP2000 THERAPY SYSTEM?

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

What is the FDA product code for LEP2000 THERAPY SYSTEM?

The FDA product code for LEP2000 THERAPY SYSTEM is NHN.

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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.