Cleared Traditional

K935772 - HP M177XA CARDIOGRAPHS (FDA 510(k) Clearance)

K935772 · Hewlett-Packard Co. · Cardiovascular device
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Jul 1994
Decision
235d
Days
-
Risk

K935772 is an FDA 510(k) clearance for the HP M177XA CARDIOGRAPHS.

Submitted by Hewlett-Packard Co. (Mcminnville, US). The FDA issued a Cleared decision on July 26, 1994 after a review of 235 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 K935772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1993
Decision Date July 26, 1994
Days to Decision 235 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 125d · This submission: 235d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -