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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 the device name listed in this FDA 510(k) record. The listed applicant is Civco Medical Solutions. It received FDA 510(k) clearance on 2019-05-24 under 510(k) 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. The listed applicant is Civco Medical Solutions. The 510(k) number is K190802.

When did Envision ultrasound pad and cover receive FDA 510(k) clearance?

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

Who is the listed applicant for Envision ultrasound pad and cover?

The FDA 510(k) record lists Civco Medical Solutions as the applicant. This does not by itself establish the device manufacturer.

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 records listing Civco Medical Solutions 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.

K233109TP Pivot Pro™ Needle Guide

Related Devices (Code: ITX)

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.

K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

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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