← Back to catalogue

OHMEGA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060166

by Medical Measurement Systems B.V.

Identifiers

510(k) Number
K060166 FDA 510(k)
FDA Product Code
FFX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1725 FDA 510(k)
Regulation Number
876.1725 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The OHMEGA is a small and lightweight ambulatory system that combines impedance recording and pH recording. It detects reflux activity using impedance and categorizes reflux episodes as acidic or non-acidic (weakly acidic) using traditional pH measurement, and analyzes gas and mixed liquid/gas reflux episodes.

The device is supplied by Medical Measurement Systems B.V. and has received FDA 510(k) clearance under K060166. It is classified as a Class II device under regulation number 876.1725, with product code FFX, and is intended for use in gastroenterology and urology settings.

Frequently asked questions

What is the OHMEGA system used for?

The OHMEGA system is used to detect reflux activity by combining impedance and pH recording, allowing clinicians to categorize reflux episodes as acidic or non-acidic and analyze gas and mixed liquid/gas reflux in gastroenterology and urology settings.

How is the OHMEGA device supplied and what is its regulatory status?

The OHMEGA is supplied by Medical Measurement Systems B.V. and has received FDA 510(k) clearance under K060166, classified as a Class II device under regulation 876.1725 with product code FFX, indicating it is substantially equivalent to a legally marketed predicate device.

Is the OHMEGA system reusable or single-use?

The device data does not specify whether the OHMEGA system is reusable or single-use; therefore, no conclusion can be drawn about its reusability from the provided information alone.

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: Medical Measurement Systems bv | Gastro-esophageal pH meter / portable ..., OHMEGA (K060166) — FDA 510 (k) | Innolitics, OHMEGA - Medical Measurement Systems B.v Trademark Registration, OHMEGA - Medical Measurement Systems B.v Trademark Registration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medical Measurement Systems B.V.

Sources (1)

  • FDA 510(k) K060166 24 fields · synced Sep 27, 2026