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FDA 510(k)

ULTRASOUND TRANSDUCER COVER

K-Number: K011265 · 2001-10-30

ApplicantAdvance Medical Designs, Inc.
Decision Date2001-10-30
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND TRANSDUCER COVER is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 2001-10-30 under 510(k) number K011265. 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 ULTRASOUND TRANSDUCER COVER?

ULTRASOUND TRANSDUCER COVER is a medical device that received FDA 510(k) clearance on 2001-10-30. The listed applicant is Advance Medical Designs, Inc.. The 510(k) number is K011265.

When did ULTRASOUND TRANSDUCER COVER receive FDA 510(k) clearance?

ULTRASOUND TRANSDUCER COVER received FDA 510(k) clearance on 2001-10-30, under 510(k) number K011265.

Who is the listed applicant for ULTRASOUND TRANSDUCER COVER?

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

What is the FDA product code for ULTRASOUND TRANSDUCER COVER?

The FDA product code for ULTRASOUND TRANSDUCER COVER is ITX.

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Other records listing Advance Medical Designs, Inc. 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.

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Related Devices (Code: 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.

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