Cleared Traditional

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

K915658 · Advanced Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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 -

Regulatory Peers - LOS

All 15
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K915658.
ECG FAX MODEM
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HP M177XA CARDIOGRAPHS
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CARDIOFAX Q ECG-8420A
K922394 · Nihon Kohden America, Inc. · Mar 1994
PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A
K895520 · Hewlett-Packard Co. · Jul 1990
Q750 ELECTROCARDIOGRAPH
K885000 · Quinton, Inc. · Feb 1989
MINGOGRAF 740 - MODEL #91-54-634
K864575 · Siemens Medical Solutions USA, Inc. · May 1987