Cleared Traditional

K981265 - PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA (FDA 510(k) Clearance)

K981265 · Hewlett-Packard Co. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1998
Decision
77d
Days
-
Risk

K981265 is an FDA 510(k) clearance for the PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCH....

Submitted by Hewlett-Packard Co. (North Attleboro, US). The FDA issued a Cleared decision on June 23, 1998 after a review of 77 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.

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Submission Details

510(k) Number K981265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1998
Decision Date June 23, 1998
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -