Amplaid EMG15

FDA 510(k) K884071 · Amplus Corp.

Substantially Equivalent

510(k) numberK884071

Submission

Device name
Amplaid EMG15
Applicant
Amplus Corp.
Boulder, CO, US
Received
September 27, 1988
Decision date
February 27, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GWL – Amplifier, Physiological Signal
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1835
Specialty
Neurology

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Questions and answers

When was Amplaid EMG15 cleared by the FDA?

Amplaid EMG15 (K884071) received a 510(k) decision of Substantially Equivalent on February 27, 1989, 153 days after the submission was received.

What is the product code of K884071?

The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.