FDA 510(k)

5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER

K-Number: K894054 · 1989-09-12

ApplicantAdvanced Technology Laboratories, Inc.

Decision Date1989-09-12

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-12 under 510(k) number K894054. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER?

5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER is a medical device that received FDA 510(k) clearance on 1989-09-12. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K894054.

When did 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER receive FDA 510(k) clearance?

5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER received FDA 510(k) clearance on 1989-09-12, under 510(k) number K894054.

Who is the listed applicant for 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER?

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

What is the FDA product code for 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER?

The FDA product code for 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER is IYN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.