Cleared Traditional

K962103 - BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-...

K962103 is an FDA 510(k) clearance for BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-..., manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K962103 · Bio-Logic Systems Corp. · Anesthesiology device
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Aug 1996
Decision
84d
Days
Class 2
Risk

K962103 is an FDA 510(k) clearance for the BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on August 22, 1996 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory 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 Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K962103

510(k) Number K962103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1996
Decision Date August 22, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Anesthesiology devices follow this clearance model.