Cleared Traditional

K772353 - EKG ACQUISITION & ANALYSIS CART

K772353 · Intl. Business Machines · Cardiovascular device
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Jan 1978
Decision
14d
Days
-
Risk

K772353 is an FDA 510(k) clearance for the EKG ACQUISITION & ANALYSIS CART.

Submitted by Intl. Business Machines (Walker, US). The FDA issued a Cleared decision on January 6, 1978 after a review of 14 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 K772353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1977
Decision Date January 06, 1978
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -