Cleared Traditional

BLOOD GAS EXPERSYSTEM 8700 (K833430) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K833430 · Medical Intelcom, Inc. · Neurology device
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Feb 1984
Decision
128d
Days
Class 3
Risk

K833430 is an FDA 510(k) clearance for the BLOOD GAS EXPERSYSTEM 8700. Classified as Stimulator, Spinal-cord, Implanted For Peripheral Vascular Disease (product code LLE), Class III - Premarket Approval.

Submitted by Medical Intelcom, Inc. (Walker, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 128 days - within the typical 510(k) review window.

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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Intelcom, Inc. devices

Submission Details

510(k) Number K833430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date February 10, 1984
Days to Decision 128 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 148d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLE Stimulator, Spinal-cord, Implanted For Peripheral Vascular Disease
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.