Cleared Traditional

K934050 - TOPOGRAPHIC BRAIN MAPPING OPTION

K934050 is an FDA 510(k) clearance for TOPOGRAPHIC BRAIN MAPPING OPTION, manufactured by Biosound, Inc.. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K934050 · Biosound, Inc. · Neurology device
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Feb 1994
Decision
168d
Days
Class 2
Risk

K934050 is an FDA 510(k) clearance for the TOPOGRAPHIC BRAIN MAPPING OPTION. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 168 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosound, Inc. devices

FDA 510(k) Submission Details - K934050

510(k) Number K934050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1993
Decision Date February 03, 1994
Days to Decision 168 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 148d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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 - OLT Non-normalizing Quantitative Electroencephalograph Software

All 17
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K934050.
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
K051883 · Ge Healthcare · Aug 2005
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
K000892 · Datex-Ohmeda, Inc. · Jun 2000
SIEMENS INFINITY EEG POD
K991012 · Siemens Medical Solutions USA, Inc. · Jun 1999
TECA NEUROMAPPER 386
K894889 · Teca, Inc. · Dec 1989
TECA NEUROMAPPER 1620, BRAIN MAPPER
K894088 · Teca, Inc. · Nov 1989
SLEEP STAGER
K850541 · Oxford Medilog, Inc. · Aug 1985