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FDA 510(k)

Envision ultrasound pad and cover

K-Number: K190802 · 2019-05-24

ApplicantCivco Medical Solutions
Decision Date2019-05-24
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Envision ultrasound pad and cover is a medical device manufactured by Civco Medical Solutions. It received FDA 510(k) clearance on 2019-05-24 under approval number K190802. 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 Envision ultrasound pad and cover?

Envision ultrasound pad and cover is a medical device that received FDA 510(k) clearance on 2019-05-24. It is manufactured by Civco Medical Solutions. The 510(k) number is K190802.

When was Envision ultrasound pad and cover approved by the FDA?

Envision ultrasound pad and cover received FDA 510(k) clearance on 2019-05-24, under approval number K190802.

What company makes Envision ultrasound pad and cover?

Envision ultrasound pad and cover is manufactured by Civco Medical Solutions.

What is the FDA product code for Envision ultrasound pad and cover?

The FDA product code for Envision ultrasound pad and cover is ITX.

Other Devices by Civco Medical Solutions

K233109TP Pivot Pro™ Needle Guide

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

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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