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FDA 510(k)

NON-PYROGENIC ULTRASOUND TRANSDUCER COVER

K-Number: K131528 · 2013-06-11

ApplicantCIVCO Medical Instruments Co., Inc.
Decision Date2013-06-11
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NON-PYROGENIC ULTRASOUND TRANSDUCER COVER is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2013-06-11 under 510(k) number K131528. 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 NON-PYROGENIC ULTRASOUND TRANSDUCER COVER?

NON-PYROGENIC ULTRASOUND TRANSDUCER COVER is a medical device that received FDA 510(k) clearance on 2013-06-11. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K131528.

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

NON-PYROGENIC ULTRASOUND TRANSDUCER COVER received FDA 510(k) clearance on 2013-06-11, under 510(k) number K131528.

Who is the listed applicant for NON-PYROGENIC ULTRASOUND TRANSDUCER COVER?

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

What is the FDA product code for NON-PYROGENIC ULTRASOUND TRANSDUCER COVER?

The FDA product code for NON-PYROGENIC ULTRASOUND TRANSDUCER COVER 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.

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