Vitalmax 840 Series

FDA 510(k) K914164 · Pace Tech Medical Monitors, Inc.

Substantially Equivalent

510(k) numberK914164

Submission

Device name
Vitalmax 840 Series
Applicant
Pace Tech Medical Monitors, Inc.
Clearwater, FL, US
Received
September 17, 1991
Decision date
April 9, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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K153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorBXN · Special Easy Med Instrument Co., Ltd.05/13/2016SE
K143095MiniStim MS-IVB Peripheral Nerve StimulatorBXN · Traditional Halyard Health, Inc.03/24/2015SE
K140853Stimpod ST2-3010 Nerve StimulatorBXN · Special Xavant Technology (Pty), Ltd.11/06/2014SE
K121743Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional Sunmed, LLC03/28/2013SE
K111985Myoguide System Model 8008BXN · Traditional Intronix Technologies Corp.12/30/2011SE
K110118Stimtrode Single Use Nerve StimulatorBXN · Special Xavant Technology (Pty), Ltd.02/17/2011SE
K102084Stimpod NMS450 Nerve StimulatorBXN · Traditional Xavant Technology (Pty), Ltd.12/16/2010SE
K093591Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional Xavant Technology (Pty), Ltd.12/03/2009SE

More from Xavant Technology (Pty), Ltd.

510(k)DeviceDecision
K970445Vitalmax 4000 Configured/Vitalmax 4000 Modular/Vitalmax 4100/MINIPACK 3100/3000/VITALMAX…MHX · Traditional 01/30/1998SE
K932203Vitalmax 530DQA · Traditional 07/19/1994SE

Questions and answers

When was Vitalmax 840 Series cleared by the FDA?

Vitalmax 840 Series (K914164) received a 510(k) decision of Substantially Equivalent on April 9, 1993, 570 days after the submission was received.

What is the product code of K914164?

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