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FDA 510(k)

TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA

K-Number: K092164 · 2010-05-13

ApplicantShenzhen Delicate Electronics Co., Ltd.
Decision Date2010-05-13
Product CodeOQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA 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 2010-05-13 under 510(k) number K092164. The device is classified under product code OQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA?

TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA is a medical device that received FDA 510(k) clearance on 2010-05-13. The listed applicant is Shenzhen Delicate Electronics Co., Ltd.. The 510(k) number is K092164.

When did TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA receive FDA 510(k) clearance?

TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA received FDA 510(k) clearance on 2010-05-13, under 510(k) number K092164.

Who is the listed applicant for TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA?

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 AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA?

The FDA product code for TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA is OQQ.

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Other records listing Shenzhen Delicate Electronics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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