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FDA 510(k)

3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA

K-Number: K851616 · 1985-07-29

ApplicantAusonics Pty , Ltd.
Decision Date1985-07-29
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA 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 1985-07-29 under 510(k) number K851616. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA?

3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA is a medical device that received FDA 510(k) clearance on 1985-07-29. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K851616.

When did 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA receive FDA 510(k) clearance?

3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA received FDA 510(k) clearance on 1985-07-29, under 510(k) number K851616.

Who is the listed applicant for 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA?

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 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA?

The FDA product code for 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA is JOP.

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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: JOP)

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.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLCK111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, Limited

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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