Cleared Traditional

ELITE II ELECTROCARDIOGRAPH,MODIFIED (K915327) - FDA 510(k) Clearance

K915327 · Siemens Burdick, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
318d
Days
-
Risk

K915327 is an FDA 510(k) clearance for the ELITE II ELECTROCARDIOGRAPH,MODIFIED.

Submitted by Siemens Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on October 9, 1992 after a review of 318 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Burdick, Inc. devices

Submission Details

510(k) Number K915327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date October 09, 1992
Days to Decision 318 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
193d slower than avg
Panel avg: 125d · This submission: 318d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 82
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