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FDA 510(k)

BIRDSONG LEVERHALER, MODEL LH-1000

K-Number: K031982 · 2004-04-02

ApplicantBirdsong Medical Devices, Inc.
Decision Date2004-04-02
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIRDSONG LEVERHALER, MODEL LH-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Birdsong Medical Devices, Inc.. It received FDA 510(k) clearance on 2004-04-02 under 510(k) number K031982. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIRDSONG LEVERHALER, MODEL LH-1000?

BIRDSONG LEVERHALER, MODEL LH-1000 is a medical device that received FDA 510(k) clearance on 2004-04-02. The listed applicant is Birdsong Medical Devices, Inc.. The 510(k) number is K031982.

When did BIRDSONG LEVERHALER, MODEL LH-1000 receive FDA 510(k) clearance?

BIRDSONG LEVERHALER, MODEL LH-1000 received FDA 510(k) clearance on 2004-04-02, under 510(k) number K031982.

Who is the listed applicant for BIRDSONG LEVERHALER, MODEL LH-1000?

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

What is the FDA product code for BIRDSONG LEVERHALER, MODEL LH-1000?

The FDA product code for BIRDSONG LEVERHALER, MODEL LH-1000 is CAF.

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Official Source

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