Cleared Traditional

K915327 - ELITE II ELECTROCARDIOGRAPH,MODIFIED

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

FDA 510(k) Submission Details - K915327

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.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

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