VitroPRO

FDA 510(k) K231783 · CIVCO Medical Instruments Co., Inc.

Substantially Equivalent

510(k) numberK231783

Submission

Device name
VitroPRO
Applicant
CIVCO Medical Instruments Co., Inc.
Kalona, IA, US
Received
June 16, 2023
Decision date
November 14, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

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 VitroPRO cleared by the FDA?

VitroPRO (K231783) received a 510(k) decision of Substantially Equivalent on November 14, 2023, 151 days after the submission was received.

What is the product code of K231783?

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