Cleared Traditional

K941282 - ECG FAX MODEM (FDA 510(k) Clearance)

K941282 · Hewlett-Packard Co. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
441d
Days
-
Risk

K941282 is an FDA 510(k) clearance for the ECG FAX MODEM.

Submitted by Hewlett-Packard Co. (Mcminnville, US). The FDA issued a Cleared decision on May 26, 1995 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

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Submission Details

510(k) Number K941282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1994
Decision Date May 26, 1995
Days to Decision 441 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
316d slower than avg
Panel avg: 125d · This submission: 441d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -