Cleared Traditional

K870920 - ELITE ELECTROCARDIOGRAPH

K870920 · Burdick Corp. · Cardiovascular device
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Apr 1987
Decision
38d
Days
-
Risk

K870920 is an FDA 510(k) clearance for the ELITE ELECTROCARDIOGRAPH.

Submitted by Burdick Corp. (Miltoon, US). The FDA issued a Cleared decision on April 13, 1987 after a review of 38 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.

View all Burdick Corp. devices

FDA 510(k) Submission Details - K870920

510(k) Number K870920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1987
Decision Date April 13, 1987
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 44
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