Cleared Traditional

K901215 - 700 SERIES BIOMAGNETOMETER

K901215 is an FDA 510(k) clearance for 700 SERIES BIOMAGNETOMETER, manufactured by Biomagnetic Technologies, Inc.. The device is a Class 2 Neurology device with product code OLX cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K901215 · Biomagnetic Technologies, Inc. · Neurology device
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Jun 1990
Decision
103d
Days
Class 2
Risk

K901215 is an FDA 510(k) clearance for the 700 SERIES BIOMAGNETOMETER. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Biomagnetic Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on June 25, 1990 after a review of 103 days - within the typical 510(k) review window.

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 Biomagnetic Technologies, Inc. devices

FDA 510(k) Submission Details - K901215

510(k) Number K901215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1990
Decision Date June 25, 1990
Days to Decision 103 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 148d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLX Device Classification - Class 2, Special Controls

Product Code OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization
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.