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FDA 510(k)

ULTRASONIC ECHOSCOPE

K-Number: K837171 · 1983-03-17

ApplicantAusonics Pty , Ltd.
Decision Date1983-03-17
Product Code
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC ECHOSCOPE 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 1983-03-17 under 510(k) number K837171. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC ECHOSCOPE?

ULTRASONIC ECHOSCOPE is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K837171.

When did ULTRASONIC ECHOSCOPE receive FDA 510(k) clearance?

ULTRASONIC ECHOSCOPE received FDA 510(k) clearance on 1983-03-17, under 510(k) number K837171.

Who is the listed applicant for ULTRASONIC ECHOSCOPE?

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

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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

View all 27 devices →

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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