EMMA— 510(k) K150174

Name: FDA 510(k) clearance K150174
Creator: U.S. Food and Drug Administration
Published: 2015-02-26

Substantially Equivalent

Inrange Systems, Inc.

FDA 510(k) clearance K150174 for EMMA, Substantially Equivalent on 2015-02-26. Applicant: Inrange Systems, Inc.. Device class: 2.

Clearance details

Applicant: Inrange Systems, Inc.
Product code: Code NZH
Device class: Class 2
Regulation: 21 CFR 880.6315
Advisory panel: General Hospital
Date received: 2015-01-26
Decision date: 2015-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Altoona, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NZH

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DEN060002 — INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM2007-06-13

Adverse events under product code NZH

product code NZH

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.