Myograph 2000

FDA 510(k) K830058 · Prothia USA, Inc.

Substantially Equivalent

510(k) numberK830058

Submission

Device name
Myograph 2000
Applicant
Prothia USA, Inc.
Mchenry, IL, US
Received
January 7, 1983
Decision date
March 7, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BXN – Stimulator, Nerve, Battery-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2775
Specialty
Anesthesiology

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More from Xavant Technology (Pty), Ltd.

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K831071Universal Instru. Set for NeurovascularGZX · Traditional 06/08/1983SE
K830993AmpligreffeGFD · Traditional 05/03/1983SE
K823581Elpha 500GCJ · Traditional 03/24/1983SE
K823583Myotest Nerve StimulatorBXN · Traditional 12/30/1982SE

Questions and answers

When was Myograph 2000 cleared by the FDA?

Myograph 2000 (K830058) received a 510(k) decision of Substantially Equivalent on March 7, 1983, 59 days after the submission was received.

What is the product code of K830058?

The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.