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FDA 510(k)

OCTOSON

K-Number: K792388 · 1979-12-20

ApplicantAusonics Pty , Ltd.
Decision Date1979-12-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OCTOSON is the device name listed in this FDA 510(k) record. The listed applicant is Ausonics Pty , Ltd.. It received FDA 510(k) clearance on 1979-12-20 under 510(k) number K792388. 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 OCTOSON?

OCTOSON is a medical device that received FDA 510(k) clearance on 1979-12-20. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K792388.

When did OCTOSON receive FDA 510(k) clearance?

OCTOSON received FDA 510(k) clearance on 1979-12-20, under 510(k) number K792388.

Who is the listed applicant for OCTOSON?

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

What is the FDA product code for OCTOSON?

The FDA product code for OCTOSON is IYO.

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Other records listing Ausonics 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.

K933916AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNERK915715CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNERK920307AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTIONK905488DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCANK9027287.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)K896714AUSONICS 5000

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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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