Highland Instruments Ces and Tus Instrument Holder

FDA 510(k) K110752 · Highland Instruments

Substantially Equivalent

510(k) numberK110752

Submission

Device name
Highland Instruments Ces and Tus Instrument Holder
Applicant
Highland Instruments
Providence, RI, US
Received
March 18, 2011
Decision date
June 28, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 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 Highland Instruments Ces and Tus Instrument Holder cleared by the FDA?

Highland Instruments Ces and Tus Instrument Holder (K110752) received a 510(k) decision of Substantially Equivalent on June 28, 2011, 102 days after the submission was received.

What is the product code of K110752?

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