FDA 510(k)

TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND

K-Number: K122710 · 2013-02-15

ApplicantShenzhen Delicate Electronics Co., Ltd.

Decision Date2013-02-15

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Delicate Electronics Co., Ltd.. It received FDA 510(k) clearance on 2013-02-15 under 510(k) number K122710. 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 TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND?

TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND is a medical device that received FDA 510(k) clearance on 2013-02-15. The listed applicant is Shenzhen Delicate Electronics Co., Ltd.. The 510(k) number is K122710.

When did TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND receive FDA 510(k) clearance?

TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND received FDA 510(k) clearance on 2013-02-15, under 510(k) number K122710.

Who is the listed applicant for TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND?

The FDA 510(k) record lists Shenzhen Delicate Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND?

The FDA product code for TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND 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.