AT33 Emg

FDA 510(k) K930578 · Autoject Systems, Inc.

Substantially Equivalent

510(k) numberK930578

Submission

Device name
AT33 Emg
Applicant
Autoject Systems, Inc.
Oak Dale, IL, US
Received
February 4, 1993
Decision date
May 19, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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Questions and answers

When was AT33 Emg cleared by the FDA?

AT33 Emg (K930578) received a 510(k) decision of Substantially Equivalent on May 19, 1995, 834 days after the submission was received.

What is the product code of K930578?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.