FDA 510(k)

DOPPLER-BOX

K-Number: K051085 · 2005-05-05

Decision Date2005-05-05

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DOPPLER-BOX is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics Germany Gmgh. It received FDA 510(k) clearance on 2005-05-05 under 510(k) number K051085. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOPPLER-BOX?

DOPPLER-BOX is a medical device that received FDA 510(k) clearance on 2005-05-05. The listed applicant is Compumedics Germany Gmgh. The 510(k) number is K051085.

When did DOPPLER-BOX receive FDA 510(k) clearance?

DOPPLER-BOX received FDA 510(k) clearance on 2005-05-05, under 510(k) number K051085.

Who is the listed applicant for DOPPLER-BOX?

The FDA 510(k) record lists Compumedics Germany Gmgh as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOPPLER-BOX?

The FDA product code for DOPPLER-BOX is IYN.

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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.