FDA 510(k)

7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)

K-Number: K902728 · 1991-02-13

Decision Date1991-02-13

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) 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 1991-02-13 under 510(k) number K902728. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)?

7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) is a medical device that received FDA 510(k) clearance on 1991-02-13. The listed applicant is Ausonics Pty , Ltd.. The 510(k) number is K902728.

When did 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) receive FDA 510(k) clearance?

7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) received FDA 510(k) clearance on 1991-02-13, under 510(k) number K902728.

Who is the listed applicant for 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)?

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 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)?

The FDA product code for 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) is ITX.

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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.