Cleared Special

K993824 - MSAS PROFESSIONAL

K993824 is an FDA 510(k) clearance for MSAS PROFESSIONAL, manufactured by Biomeridian, Int.. The device is a Class 2 Neurology device with product code GZO cleared through the Special 510(k) pathway after a 69-day FDA review.

K993824 · Biomeridian, Int. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
69d
Days
Class 2
Risk

K993824 is an FDA 510(k) clearance for the MSAS PROFESSIONAL. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Biomeridian, Int. (Draper, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1540 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K993824

510(k) Number K993824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date January 20, 2000
Days to Decision 69 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 149d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

GZO Device Classification - Class 2, Special Controls

Product Code GZO Device, Galvanic Skin Response Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1540
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZO Device, Galvanic Skin Response Measurement

All 24
Devices cleared under the same product code (GZO) and FDA review panel - the closest regulatory comparables to K993824.
MERIDIAN-PORTABLE
K010897 · Meridian Co., Ltd. · Jun 2001
BIOFIND
K003480 · Bio-Scan, Inc. · May 2001
MERIDIAN-II AND MERDIAN-PLUS
K001347 · Meridian Co., Ltd. · Nov 2000
EIM-107 PREP-CHECK
K993202 · General Devices · Dec 1999
PHAZX VLD-100
K992129 · Phazx Systems, Inc. · Sep 1999
E-READER
K970436 · Natural Herbal Products, Inc. · Aug 1997
K993824 · MSAS PROFESSIONAL
Download PDF FDA Summary Biomeridian, Int.