Cleared Traditional

K844104 - CARDIO ANALYZER MODEL 380 (FDA 510(k) Clearance)

K844104 · Birtcher Corp. · Cardiovascular device
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Mar 1985
Decision
134d
Days
-
Risk

K844104 is an FDA 510(k) clearance for the CARDIO ANALYZER MODEL 380.

Submitted by Birtcher Corp. (El Monte, US). The FDA issued a Cleared decision on March 6, 1985 after a review of 134 days - within the typical 510(k) review window.

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.

View all Birtcher Corp. devices

Submission Details

510(k) Number K844104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date March 06, 1985
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -