Medar Apm Force Transducer

FDA 510(k) K853849 · Medar Corp., Inc.

Substantially Equivalent

510(k) numberK853849

Submission

Device name
Medar Apm Force Transducer
Applicant
Medar Corp., Inc.
Scarsdale, NY, US
Received
September 16, 1985
Decision date
January 3, 1986
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

Other 510(k)s with product code BXN

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K153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorBXN · Special Easy Med Instrument Co., Ltd.05/13/2016SE
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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

Questions and answers

When was Medar Apm Force Transducer cleared by the FDA?

Medar Apm Force Transducer (K853849) received a 510(k) decision of Substantially Equivalent on January 3, 1986, 109 days after the submission was received.

What is the product code of K853849?

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