Smartdop 30 Bi-Directional Blood Flow Detector
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K942613 FDA 510(k)
- FDA Product Code
- DPW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2100 FDA 510(k)
- Regulation Number
- 870.2100 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Smartdop 30 Bi-Directional Blood Flow Detector is a flowmeter, blood, cardiovascular device used for the diagnosis and monitoring of vascular arterial and venous conditions. It is a bi-directional vascular Doppler with features such as an inflation port and LCD display. The device is classified as a Class II device with special controls.
The Smartdop 30 Bi-Directional Blood Flow Detector is supplied by Koven Technology, Inc. and has received FDA 510(k) clearance. The device is intended for use in a clinical setting and is regulated under product code DPW. The clearance was issued on December 23, 1994, after a review of 204 days.
Frequently asked questions
What is the Smartdop 30 used for?
The Smartdop 30 is used for the diagnosis and monitoring of vascular arterial and venous conditions in a clinical setting.
Is the Smartdop 30 a single-use device?
The device data does not specify if the Smartdop 30 is single-use or reusable, but it is classified as a Class II device with special controls.
What features does the Smartdop 30 have?
The Smartdop 30 has features such as an inflation port and LCD display, making it a bi-directional vascular Doppler.
What is the regulatory status of the Smartdop 30?
The Smartdop 30 has received FDA 510(k) clearance, which was issued on December 23, 1994, after a review of 204 days.
How is the Smartdop 30 supplied?
The Smartdop 30 is supplied by Koven Technology, Inc.
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: Smartdop 30EX Vascular Doppler | Koven Technology, Inc., K942613 - Smartdop 30 Bi-directional Blood Flow Detector, Smartdop 30 Bi-directional Blood Flow Detector, Smartdop 30EX | Wound Care Doppler | Built-in PVR
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K942613 | Class II | Active |
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Manufacturer
- Manufacturer
- Koven Technology, Inc.
Sources (1)
- FDA 510(k) K942613 24 fields · synced Sep 26, 2026