Cleared Traditional

K890513 - SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)

K890513 is an FDA 510(k) clearance for SAC 747 AND SAC 847 (SLEEP ANALYZING CO..., manufactured by Micro Tronics Corp.. The device is a Class 2 Neurology device with product code OLZ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K890513 · Micro Tronics Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
86d
Days
Class 2
Risk

K890513 is an FDA 510(k) clearance for the SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS). Classified as Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ), Class II - Special Controls.

Submitted by Micro Tronics Corp. (Carrboro, US). The FDA issued a Cleared decision on April 28, 1989 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro Tronics Corp. devices

FDA 510(k) Submission Details - K890513

510(k) Number K890513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1989
Decision Date April 28, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 148d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLZ Device Classification - Class 2, Special Controls

Product Code OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By 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 - OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

All 33
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K890513.
MEDILOG VISION
K961636 · Oxford Instruments, Plc. · Jan 1997
SENSORMEDICS 4000 SERIES SLEEP SYSTEM
K915856 · Sensor Medics Corp. · Oct 1992
MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM
K891383 · Oxford Medilog, Inc. · Jun 1989
MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.
K871990 · Oxford Medilog, Inc. · Oct 1987