Medical Monitor 32HR734S
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241402 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medical Monitor 32HR734S is a gastrointestinal pressure monitoring device designed to measure and record intraluminal pressures within the gastrointestinal tract. It provides real-time data for diagnostic and therapeutic assessment of motility disorders, reflux, or other functional abnormalities in the esophagus, stomach, or intestines.
This device is intended for single-use in clinical settings such as hospitals, endoscopy suites, or outpatient diagnostic centers. Supplied sterile and pre-sterilized, it adheres to FDA 510(k) clearance and MDR compliance, ensuring compatibility with regulatory standards. The device is non-MRI safe and must be handled according to manufacturer guidelines for proper calibration and disposal.
Frequently asked questions
What clinical conditions is this device primarily used to diagnose or assess in patients?
The Medical Monitor (32HR734S) is designed to measure and record intraluminal pressures in the gastrointestinal tract, helping clinicians diagnose or assess motility disorders, reflux, or functional abnormalities in the esophagus, stomach, or intestines. It provides real-time data for diagnostic and therapeutic evaluations in these areas.
Is this device intended for repeated use in the same patient, or is it meant to be used only once?
This device is explicitly intended for single-use in clinical settings like hospitals, endoscopy suites, or outpatient diagnostic centers. It is supplied sterile and pre-sterilized, ensuring it meets regulatory standards for one-time clinical application.
How should this device be stored before use, and are there any special handling requirements?
The Medical Monitor (32HR734S) is supplied sterile and pre-sterilized, so it must be stored according to the manufacturer’s guidelines to maintain sterility. Since it is single-use, it should be kept in its original packaging until immediately before use, protected from contamination and environmental exposure.
Can this device be used in an MRI environment, or are there any safety restrictions?
The device is explicitly labeled as non-MRI safe, meaning it should not be used in or near an MRI scanner. Clinicians must follow the manufacturer’s guidelines for proper handling and disposal to avoid potential risks.
What regulatory pathways does this device follow, and how does that affect its use?
The Medical Monitor (32HR734S) follows FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, confirming it meets U.S. and EU regulatory standards for safety and performance. These pathways ensure the device adheres to strict manufacturing, labeling, and clinical use requirements, but they do not dictate its clinical indications—only that it has been reviewed for market authorization.
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 (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241402 | Class II | Active |
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Manufacturer
- Manufacturer
- LG Electronics Inc.
- FDA Applicant
- Lg Electronics.Inc
Sources (2)
- FDA 510(k) K241402 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026