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FDA 510(k)

RESUBMITTAL OF MI 1000C MICROIMAGER

K-Number: K881979 · 1989-06-12

ApplicantAusonics Pty , Ltd.
Decision Date1989-06-12
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RESUBMITTAL OF MI 1000C MICROIMAGER 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 1989-06-12 under 510(k) number K881979. 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 RESUBMITTAL OF MI 1000C MICROIMAGER?

RESUBMITTAL OF MI 1000C MICROIMAGER is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K881979.

When did RESUBMITTAL OF MI 1000C MICROIMAGER receive FDA 510(k) clearance?

RESUBMITTAL OF MI 1000C MICROIMAGER received FDA 510(k) clearance on 1989-06-12, under 510(k) number K881979.

Who is the listed applicant for RESUBMITTAL OF MI 1000C MICROIMAGER?

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 RESUBMITTAL OF MI 1000C MICROIMAGER?

The FDA product code for RESUBMITTAL OF MI 1000C MICROIMAGER 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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