Adms Multiplane Rectal Probe

FDA 510(k) K895359 · Avalon Technology Corp.

Substantially Equivalent

510(k) numberK895359

Submission

Device name
Adms Multiplane Rectal Probe
Applicant
Avalon Technology Corp.
Indianapolis, IN, US
Received
August 28, 1989
Decision date
November 22, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Adms Multiplane Rectal Probe cleared by the FDA?

Adms Multiplane Rectal Probe (K895359) received a 510(k) decision of Substantially Equivalent on November 22, 1989, 86 days after the submission was received.

What is the product code of K895359?

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