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FDA 510(k)

SPEQ ULTRASOUND SYSTEM

K-Number: K090505 · 2009-05-07

ApplicantSignostics Pty, Ltd.
Decision Date2009-05-07
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPEQ ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Signostics Pty, Ltd.. It received FDA 510(k) clearance on 2009-05-07 under 510(k) number K090505. 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 SPEQ ULTRASOUND SYSTEM?

SPEQ ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-07. The listed applicant is Signostics Pty, Ltd.. The 510(k) number is K090505.

When did SPEQ ULTRASOUND SYSTEM receive FDA 510(k) clearance?

SPEQ ULTRASOUND SYSTEM received FDA 510(k) clearance on 2009-05-07, under 510(k) number K090505.

Who is the listed applicant for SPEQ ULTRASOUND SYSTEM?

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

What is the FDA product code for SPEQ ULTRASOUND SYSTEM?

The FDA product code for SPEQ ULTRASOUND SYSTEM is IYO.

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.

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Other records listing Signostics Pty, 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.

K130659SPEQRT ULTRASOUND SYSTEM

Related Devices (Code: IYO)

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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