Msas Professional

FDA 510(k) K993824 · Biomeridian, Int.

Substantially Equivalent

510(k) numberK993824

Submission

Device name
Msas Professional
Applicant
Biomeridian, Int.
Draper, UT, US
Received
November 12, 1999
Decision date
January 20, 2000
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZO – Device, Galvanic Skin Response Measurement
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1540
Specialty
Neurology

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K150804QBioScanGZO · Traditional Medeia, Inc.10/19/2015SE
K152216SudoCGZO · Special Ld Technology, LLC09/24/2015SE
K141872SudoscanGZO · Traditional Impeto Medical, Inc.11/21/2014SE
K131568Sudo PathGZO · Special Ld Technology, LLC06/28/2013SE
K111308Zyto Hand CradleGZO · Traditional Zyto Technologies, Inc.08/30/2011SE
K102166Electro Interstitial ScanGZO · Traditional Ld Technology, LLC12/10/2010SE
K100233SudoscanGZO · Traditional Impeto Medical06/14/2010SE
K053004Msas-VantageGZO · Special Biomeridian, Int.01/13/2006SE
K032935Epi-Scan, Model P 100GZO · Special Edx Epi-Scan, Inc.11/20/2003SE
K023355AsyraGZO · Traditional Galloway Technologies, LLC06/24/2003SE

More from Galloway Technologies, LLC

510(k)DeviceDecision
K053004Msas-VantageGZO · Special 01/13/2006SE

Questions and answers

When was Msas Professional cleared by the FDA?

Msas Professional (K993824) received a 510(k) decision of Substantially Equivalent on January 20, 2000, 69 days after the submission was received.

What is the product code of K993824?

The FDA product code is GZO – Device, Galvanic Skin Response Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1540.