FDA 510(k)

EMM Ultrasonic Transducer Cover

K-Number: K211969 · 2021-08-13

Decision Date2021-08-13

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EMM Ultrasonic Transducer Cover is a medical device manufactured by Exact Medical Manufacturing. It received FDA 510(k) clearance on 2021-08-13 under approval number K211969. 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 EMM Ultrasonic Transducer Cover?

EMM Ultrasonic Transducer Cover is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Exact Medical Manufacturing. The 510(k) number is K211969.

When was EMM Ultrasonic Transducer Cover approved by the FDA?

EMM Ultrasonic Transducer Cover received FDA 510(k) clearance on 2021-08-13, under approval number K211969.

What company makes EMM Ultrasonic Transducer Cover?

EMM Ultrasonic Transducer Cover is manufactured by Exact Medical Manufacturing.

What is the FDA product code for EMM Ultrasonic Transducer Cover?

The FDA product code for EMM Ultrasonic Transducer Cover is ITX.

Other Devices by Exact Medical Manufacturing

K222460Intraoperative Ultrasound Probe Cover

Related Devices (Code: ITX)

K152126UST-5550-R; UST-5536-R; L43KHitachi Aloka Medical America, Inc. K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc. K160414Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC K153212Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeKoelis K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc.

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.