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FDA 510(k)

ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K963616 · 1997-04-03

Decision Date1997-04-03
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALOKA SSD-1700 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 1997-04-03 under 510(k) number K963616. 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 ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM?

ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-03. The listed applicant is Aloka Co., Ltd.. The 510(k) number is K963616.

When did ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 1997-04-03, under 510(k) number K963616.

Who is the listed applicant for ALOKA SSD-1700 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 SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM is IYN.

Related Clinical Trials

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.

Other records listing Aloka 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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Related Devices (Code: IYN)

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.

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.

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