Cleared Traditional

K915658 - SPECTRA ECG (FDA 510(k) Clearance)

K915658 · Advanced Medical Products, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1992
Decision
175d
Days
-
Risk

K915658 is an FDA 510(k) clearance for the SPECTRA ECG.

Submitted by Advanced Medical Products, Inc. (Liverpool, US). The FDA issued a Cleared decision on June 10, 1992 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Advanced Medical Products, Inc. devices

Submission Details

510(k) Number K915658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1991
Decision Date June 10, 1992
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -