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FDA 510(k)

ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K093488 · 2009-11-20

ApplicantAloka Co., Ltd.
Decision Date2009-11-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aloka Co., Ltd.. It received FDA 510(k) clearance on 2009-11-20 under 510(k) number K093488. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM?

ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-20. The listed applicant is Aloka Co., Ltd.. The 510(k) number is K093488.

When did ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2009-11-20, under 510(k) number K093488.

Who is the listed applicant for ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM?

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

What is the FDA product code for ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM is IYO.

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Other records listing Aloka Co., Ltd. as applicant

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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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