AR1000 Ultrasonic Wound Therapy System

FDA 510(k) K062544 · Arobella Medical, LLC

Substantially Equivalent

510(k) numberK062544

Submission

Device name
AR1000 Ultrasonic Wound Therapy System
Applicant
Arobella Medical, LLC
Carmel, IN, US
Received
August 30, 2006
Decision date
January 3, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LFL – Instrument, Ultrasonic Surgical
Device class
Unclassified

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Questions and answers

When was AR1000 Ultrasonic Wound Therapy System cleared by the FDA?

AR1000 Ultrasonic Wound Therapy System (K062544) received a 510(k) decision of Substantially Equivalent on January 3, 2007, 126 days after the submission was received.

What is the product code of K062544?

The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.