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FDA 510(k)

6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE

K-Number: K953773 · 1996-03-14

ApplicantMedison America, Inc.
Decision Date1996-03-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Medison America, Inc.. It received FDA 510(k) clearance on 1996-03-14 under 510(k) number K953773. 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 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE?

6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE is a medical device that received FDA 510(k) clearance on 1996-03-14. The listed applicant is Medison America, Inc.. The 510(k) number is K953773.

When did 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE receive FDA 510(k) clearance?

6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE received FDA 510(k) clearance on 1996-03-14, under 510(k) number K953773.

Who is the listed applicant for 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE?

The FDA 510(k) record lists Medison America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE?

The FDA product code for 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE is IYO.

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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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