Prager Shell

FDA 510(k) K082893 · Esi, Inc.

Substantially Equivalent

510(k) numberK082893

Submission

Device name
Prager Shell
Applicant
Esi, Inc.
Hasbrouck Heights, NJ, US
Received
September 30, 2008
Decision date
December 5, 2008
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 Prager Shell cleared by the FDA?

Prager Shell (K082893) received a 510(k) decision of Substantially Equivalent on December 5, 2008, 66 days after the submission was received.

What is the product code of K082893?

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