Cleared Traditional

PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO (K954980) - FDA 510(k) Clearance

K954980 · Hewlett-Packard Co. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1996
Decision
197d
Days
-
Risk

K954980 is an FDA 510(k) clearance for the PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO.

Submitted by Hewlett-Packard Co. (Mcminnville, US). The FDA issued a Cleared decision on May 15, 1996 after a review of 197 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 K954980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1995
Decision Date May 15, 1996
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 14
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