Cleared Traditional

K930564 - HOLTER FOR WINDOWS

K930564 is an FDA 510(k) clearance for HOLTER FOR WINDOWS, manufactured by North East Monitoring, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 805-day FDA review.

K930564 · North East Monitoring, Inc. · Cardiovascular device
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Apr 1995
Decision
805d
Days
Class 2
Risk

K930564 is an FDA 510(k) clearance for the HOLTER FOR WINDOWS. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by North East Monitoring, Inc. (Sudbury, US). The FDA issued a Cleared decision on April 19, 1995 after a review of 805 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all North East Monitoring, Inc. devices

FDA 510(k) Submission Details - K930564

510(k) Number K930564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1993
Decision Date April 19, 1995
Days to Decision 805 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
680d slower than avg
Panel avg: 125d · This submission: 805d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 284
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K930564.
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K941762 · Hogan & Hartson · Feb 1995
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K942565 · Burdick Corp. · Dec 1994
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K925285 · B. Braun of America, Inc. · Jul 1993