Cleared Traditional

STRESS/EMERGENCY EELCTRODE (K790883) - FDA 510(k) Clearance

K790883 · Hayes Products, Inc. · Neurology device
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Jul 1979
Decision
76d
Days
-
Risk

K790883 is an FDA 510(k) clearance for the STRESS/EMERGENCY EELCTRODE.

Submitted by Hayes Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 24, 1979 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel. 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 Hayes Products, Inc. devices

Submission Details

510(k) Number K790883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1979
Decision Date July 24, 1979
Days to Decision 76 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 148d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -