Cleared Abbreviated

K071782 - MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES

K071782 is an FDA 510(k) clearance for MICROMED BRAIN SPY PLUS, manufactured by Micromed S.P.A.. The device is a Class 2 Neurology device with product code OLV cleared through the Abbreviated 510(k) pathway after a 192-day FDA review.

K071782 · Micromed S.P.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
192d
Days
Class 2
Risk

K071782 is an FDA 510(k) clearance for the MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Micromed S.P.A. (Mogliano Veneto (Tv), IT). The FDA issued a Cleared decision on January 10, 2008 after a review of 192 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Micromed S.P.A. devices

FDA 510(k) Submission Details - K071782

510(k) Number K071782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date January 10, 2008
Days to Decision 192 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 149d · This submission: 192d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

OLV Device Classification - Class 2, Special Controls

Product Code OLV Standard Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.
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 Consultant

Kema Quality B.V.
JAN VAN LOCHEM

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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