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FDA 510(k)

ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1

K-Number: K081843 · 2008-07-15

ApplicantAloka Co., Ltd.
Decision Date2008-07-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 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 2008-07-15 under 510(k) number K081843. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1?

ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 is a medical device that received FDA 510(k) clearance on 2008-07-15. The listed applicant is Aloka Co., Ltd.. The 510(k) number is K081843.

When did ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 receive FDA 510(k) clearance?

ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 received FDA 510(k) clearance on 2008-07-15, under 510(k) number K081843.

Who is the listed applicant for ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1?

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 ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1?

The FDA product code for ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 is LLZ.

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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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