Cleared Traditional

K840232 - ABM ANESTHESIA & BRAIN MONITOR (FDA 510(k) Clearance)

K840232 · Datex Division Instrumentarium Corp. · Cardiovascular device
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Apr 1984
Decision
87d
Days
-
Risk

K840232 is an FDA 510(k) clearance for the ABM ANESTHESIA & BRAIN MONITOR.

Submitted by Datex Division Instrumentarium Corp. (Helsinki 10 Finland, US). The FDA issued a Cleared decision on April 6, 1984 after a review of 87 days - a notably fast clearance 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: 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 Datex Division Instrumentarium Corp. devices

Submission Details

510(k) Number K840232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1984
Decision Date April 06, 1984
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -