Zymed Holter Scanner Model 2010
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K930806 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Zymed Holter Scanner Model 2010 is a computerized Holter analyzer designed for clinical environments. It processes 2 or 3-channel digital Holter tape recordings to perform arrhythmia analysis, ST segment analysis, and HRV-Time Domain analysis.
The system utilizes an Intel Pentium CPU and supports both prospective, technician-supervised real-time tuning and retrospective automated operation modes. This device has received FDA 510(k) clearance under K930806.
Frequently asked questions
What clinical functions does the Zymed Holter Scanner Model 2010 perform?
This system is designed to process 2 or 3-channel digital Holter tape recordings. It performs specific clinical assessments including arrhythmia analysis, ST segment analysis, and HRV-Time Domain analysis.
What operational modes are available for this Holter analyzer?
The system supports two distinct operational modes: prospective, technician-supervised real-time tuning and retrospective automated operation, providing flexibility for different clinical workflows.
What is the regulatory status of the Zymed Holter Scanner Model 2010?
The device has received FDA 510(k) clearance under K930806, having been determined to be substantially equivalent to other devices in the cardiovascular product category.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ZYMED HOLTER SCANNER MODEL 2010 (K930806) — FDA 510 (k) | Innolitics, ZYMED HOLTER SCANNER MODEL 2010 (K955015) — FDA 510 (k) | Innolitics, Agilent Zymed Holter Scanner 2010 - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K930806 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Agilent Technologies
Sources (1)
- FDA 510(k) K930806 24 fields · synced Sep 25, 2026