Envision ultrasound pad and cover

FDA 510(k) K190802 · Civco Medical Solutions

Substantially Equivalent

510(k) numberK190802

Submission

Device name
Envision ultrasound pad and cover
Applicant
Civco Medical Solutions
Kalona, IA, US
Received
March 29, 2019
Decision date
May 24, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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Questions and answers

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

Envision ultrasound pad and cover (K190802) received a 510(k) decision of Substantially Equivalent on May 24, 2019, 56 days after the submission was received.

What is the product code of K190802?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.