Identifiers
- 510(k) Number
- K191110 FDA 510(k)
- FDA Product Code
- KNG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2660 FDA 510(k)
- Regulation Number
- 884.2660 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HeraBEAT US is an Ultrasonic Fetal Monitor, a device used in the medical specialty of Obstetrics/Gynecology. It is classified as a device class 2 product. The device is used for monitoring purposes. The HeraBEAT US is a type of monitor that utilizes ultrasonic technology.
The HeraBEAT US is supplied with a product code of KNG and a regulation number of 884.2660. It has been authorized with an FDA 510K clearance. The device is associated with multiple fei numbers and registration numbers. The HeraBEAT US is used in the field of Obstetrics/Gynecology, with a review advisory committee of OB.
Frequently asked questions
What is the HeraBEAT US used for?
The HeraBEAT US is used for monitoring purposes in the field of Obstetrics/Gynecology, specifically as an ultrasonic fetal monitor.
What type of clearance does the HeraBEAT US have?
The HeraBEAT US has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.
What is the product code for the HeraBEAT US?
The HeraBEAT US has a product code of KNG and a regulation number of 884.2660.
What medical specialty is the HeraBEAT US associated with?
The HeraBEAT US is associated with the medical specialty of Obstetrics/Gynecology, with a review advisory committee of OB.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191110 | Class II | Active |
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Manufacturer
- Manufacturer
- Heramed, Ltd.
Sources (1)
- FDA 510(k) K191110 24 fields · synced Sep 27, 2026