Cleared Traditional

K963174 - HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)

K963174 is an FDA 510(k) clearance for HOLTER DIGICORDER WITH PACER OPTION (MO..., manufactured by Del Mar Avionics. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K963174 · Del Mar Avionics · Cardiovascular device
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Mar 1997
Decision
211d
Days
Class 2
Risk

K963174 is an FDA 510(k) clearance for the HOLTER DIGICORDER WITH PACER OPTION (MODEL 483). Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on March 13, 1997 after a review of 211 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. 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 Del Mar Avionics devices

FDA 510(k) Submission Details - K963174

510(k) Number K963174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1996
Decision Date March 13, 1997
Days to Decision 211 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 125d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSH Recorder, Magnetic Tape, Medical

All 112
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