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Vasomedical-Biox™ ARCS ABP Analysis & Reporting Software & Dongle
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Vasomedical-Biox™ ARCS ABP Analysis & Reporting Software & Dongle FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
- Device Name
- ARCS ABP Analysis & Reporting Software & Dongle FDA UDI
- Model / Reference
- ARCS Series S/W FDA UDI
- Description
- ARCS ABP Analysis & Reporting Software & Dongle FDA UDI
Identifiers
- Catalog Number
- A10-0118-50 FDA UDI
- Primary DI / UDI-DI
- 00817980020283 FDA UDI
- 510(k) Number
- K092785 FDA UDI
- FDA Product Code
- DSH FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic long-term ambulatory recording analyser application software
Vasomedical-Biox™ ARCS ABP Analysis & Reporting Software & Dongle by Vasomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092785 also covers:
- Vasomedical-Biox™ 2301 Combined 3 Channel ECG Holter & ABP Monitor — VASOMEDICAL, INC.
- Vasomedical-Biox™ 2304 Combined 12 Channel ECG Holter & ABP Monitor — VASOMEDICAL, INC.
- Vasomedical-Biox™ 2305 Combined 3 CH ECG Holter & ABP Monitor with Bluetooth — VASOMEDICAL, INC.
- Vasomedical-Biox™ 2306 Combined 12 CH ECG Holter & ABP Monitor with Bluetooth — VASOMEDICAL, INC.
- Vasomedical-Biox™ ARCS ABP Analysis & Reporting S/W & Dongle w/Bluetooth — VASOMEDICAL, INC.
- Vasomedical-Biox™ ARCS Analysis & Reporting S/W & Dongle, 3 CH ECG, USB — VASOMEDICAL, INC.
- Vasomedical-Biox™ ARCS Analysis & Reporting S/W Dongle Only, 12 CH ECG — VASOMEDICAL, INC.
- Vasomedical-Biox™ ARCS Analysis & Reporting S/w & Dongle, 12 CH ECG, USB — VASOMEDICAL, INC.
- Vasomedical-Biox™ ARCS Analysis & Reporting Software Dongle Only, 3 CH ECG — VASOMEDICAL, INC.
- Vasomedical-Biox™ ARCS S/W & Dongle - Mini 1200 / 1201, 2 & 3 CH ECG — VASOMEDICAL, INC.
- Vasomedical-Biox™ ARCS S/W & Dongle - Mini 1200/1201 2 & 3 CH ECG, USB — VASOMEDICAL, INC.
- Vasomedical-Biox™ ARCS S/W & Dongle, Comb (12 CH ECG & ABP), USB — VASOMEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vasomedical, Inc.
Sources (1)
- FDA UDI e87387a6-1e32-4e55-87f2-cf61346e0164 36 fields · synced May 30, 2026