EMMA

Medication Management System, Remote

INRANGE SYSTEMS, INC.

The following data is part of a premarket notification filed by Inrange Systems, Inc. with the FDA for Emma.

Pre-market Notification Details

• Device ID: K150174
• 510k Number: K150174
• Device Name: EMMA
• Classification: Medication Management System, Remote
• Applicant: INRANGE SYSTEMS, INC. 3316 5th Avenue - Suite 100 Altoona, PA 16602
• Contact: Christopher E Bossi
• Correspondent: Christopher E Bossi; INRANGE SYSTEMS, INC. 3316 5th Avenue - Suite 100 Altoona, PA 16602
• Product Code: NZH
• CFR Regulation Number: 880.6315 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-01-26
• Decision Date: 2015-02-26