MMC Amplifier

FDA 510(k) K943673 · Melville Software , Ltd.

Substantially Equivalent

510(k) numberK943673

Submission

Device name
MMC Amplifier
Applicant
Melville Software , Ltd.
Ottawa, Ontario, CA
Received
July 26, 1994
Decision date
October 26, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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 MMC Amplifier cleared by the FDA?

MMC Amplifier (K943673) received a 510(k) decision of Substantially Equivalent on October 26, 1994, 92 days after the submission was received.

What is the product code of K943673?

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