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EMMA

by Inrange Systems, Inc.

510(k) K150174

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK150174 Date26 Feb 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NZH
Device Class
Class II
Regulation
21 CFR Part 880.6315
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

EMMA is a remote medication management system designed to facilitate documented medication administration in hospitals. The system manages outpatient medication delivery by selecting and delivering individual doses of medication according to physician and pharmacist instructions.

EMMA is supplied as a system that includes the EMMA E-Kit for individual unit dose control of narcotics and non-narcotics, and the EMMA E-Cabinet solution. The device is FDA 510K cleared with product code NZH and is intended for use in general hospital settings.

Other devices from Inrange Systems, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the EMMA system designed for?

    EMMA is a remote medication management system designed to facilitate documented medication administration in hospitals by managing outpatient medication delivery through selecting and delivering individual doses of medication according to physician and pharmacist instructions.

  • What components are included in the EMMA system?

    The EMMA system is supplied as a complete solution that includes the EMMA E-Kit for individual unit dose control of narcotics and non-narcotics, and the EMMA E-Cabinet solution for comprehensive medication management in hospital settings.

  • What is the regulatory status of the EMMA system?

    The EMMA device is FDA 510K cleared with product code NZH and is intended for use in general hospital settings. It received clearance on February 26, 2015, as substantially equivalent to predicate devices.

  • How is the EMMA system supplied?

    The EMMA system is supplied as a complete solution including both the EMMA E-Kit for individual unit dose control and the EMMA E-Cabinet solution, designed to work together for comprehensive medication management in hospital environments.