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FDA 510(k)

ULTRASONIC NEBULISER MODEL 2010

K-Number: K072136 · 2008-07-15

ApplicantWilfred Kromker GmbH
Decision Date2008-07-15
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC NEBULISER MODEL 2010 is the device name listed in this FDA 510(k) record. The listed applicant is Wilfred Kromker GmbH. It received FDA 510(k) clearance on 2008-07-15 under 510(k) number K072136. 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 ULTRASONIC NEBULISER MODEL 2010?

ULTRASONIC NEBULISER MODEL 2010 is a medical device that received FDA 510(k) clearance on 2008-07-15. The listed applicant is Wilfred Kromker GmbH. The 510(k) number is K072136.

When did ULTRASONIC NEBULISER MODEL 2010 receive FDA 510(k) clearance?

ULTRASONIC NEBULISER MODEL 2010 received FDA 510(k) clearance on 2008-07-15, under 510(k) number K072136.

Who is the listed applicant for ULTRASONIC NEBULISER MODEL 2010?

The FDA 510(k) record lists Wilfred Kromker GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASONIC NEBULISER MODEL 2010?

The FDA product code for ULTRASONIC NEBULISER MODEL 2010 is CAF.

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Official Source

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