Cleared Traditional

K770788 - ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K770788 · Storz Instrument Co. · Neurology device
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May 1977
Decision
4d
Days
Class 2
Risk

K770788 is an FDA 510(k) clearance for the ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000. Classified as Echoencephalograph (product code GXW), Class II - Special Controls.

Submitted by Storz Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on May 6, 1977 after a review of 4 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1240 - 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 Storz Instrument Co. devices

Submission Details

510(k) Number K770788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1977
Decision Date May 06, 1977
Days to Decision 4 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d faster than avg
Panel avg: 148d · This submission: 4d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXW Echoencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1240
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.