Cleared Traditional

K990093 - ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW

K990093 is an FDA 510(k) clearance for ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW, manufactured by Agilent Technologies. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K990093 · Agilent Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
120d
Days
Class 2
Risk

K990093 is an FDA 510(k) clearance for the ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Agilent Technologies (Camarillo, US). The FDA issued a Cleared decision on May 11, 1999 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Agilent Technologies devices

FDA 510(k) Submission Details - K990093

510(k) Number K990093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1999
Decision Date May 11, 1999
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 275
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K990093.
MUSE CARDIOVASCULAR INFORMATION SYSTEM
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HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
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HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P
K991773 · Hewlett-Packard GmbH · Jun 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T
K990972 · Hewlett-Packard GmbH · Apr 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K
K990125 · Hewlett-Packard GmbH · Jan 1999
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
K981376 · Hewlett-Packard Co. · Jan 1999