Cleared Traditional

K833884 - ISOTEC DISPOS. PRESSURE TRANSDUCER (FDA 510(k) Clearance)

K833884 · Delta Medical Industries · Cardiovascular device
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Apr 1984
Decision
160d
Days
-
Risk

K833884 is an FDA 510(k) clearance for the ISOTEC DISPOS. PRESSURE TRANSDUCER.

Submitted by Delta Medical Industries (Walker, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 160 days - an extended review cycle.

This device falls under the Cardiovascular 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K833884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1983
Decision Date April 17, 1984
Days to Decision 160 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 125d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -