Identifiers
- 510(k) Number
- K944196 FDA 510(k)
- FDA Product Code
- JAF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1540 FDA 510(k)
- Regulation Number
- 892.1540 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Imwxdop Ir is an Ultrasonic, Nonfetal Monitor, classified as a Class 2 device. It is used in the field of Radiology. The device is substantially equivalent and has a product code of JAF.
The Imwxdop Ir is supplied by Imex Medical Systems, Inc. and has been cleared under the FDA 510(k) with the k-number K944196. The device has a registration number and a regulation number of 892.1540. It is used in radiology and has been cleared since 1995.
Frequently asked questions
What is the Imwxdop Ir used for?
The Imwxdop Ir is used in the field of Radiology as an ultrasonic nonfetal monitor.
Is the Imwxdop Ir a single-use or reusable device?
The device data does not specify whether the Imwxdop Ir is single-use or reusable, but it is classified as a Class 2 device.
What is the regulatory status of the Imwxdop Ir?
The Imwxdop Ir has been cleared under the FDA 510(k) with the k-number K944196, and has a regulation number of 892.1540.
Who is the manufacturer of the Imwxdop Ir?
The Imwxdop Ir is supplied by Imex Medical Systems, 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: Imex Imwxdop Ir - allmed.wiki, K944196 FDA 510(k) - IMWXDOP IR | Imex Medical Systems, Inc., IMWXDOP IR (K944196) — FDA 510(k) | Innolitics, IMWXDOP IR — K944196 · DeviceClearance, Imwxdop Ir 510 (k) FDA Premarket Notification K944196 IMEX MEDICAL ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K944196 | Class II | Active |
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Manufacturer
- Manufacturer
- Imex Medical Systems, Inc.
Sources (1)
- FDA 510(k) K944196 24 fields · synced Sep 26, 2026