STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast

FDA 510(k) K150220 · Eb Neuro S.P.A.

Substantially Equivalent

510(k) numberK150220

Submission

Device name
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
Applicant
Eb Neuro S.P.A.
Florence, IT
Received
January 30, 2015
Decision date
August 19, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWF – Stimulator, Electrical, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1870
Specialty
Neurology

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Questions and answers

When was STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast cleared by the FDA?

STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast (K150220) received a 510(k) decision of Substantially Equivalent on August 19, 2015, 201 days after the submission was received.

What is the product code of K150220?

The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.