Cleared Traditional

K844104 - CARDIO ANALYZER MODEL 380

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

FDA 510(k) Submission Details - K844104

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 44
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