MINI-MEDIC

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

ATHENA GTX

The following data is part of a premarket notification filed by Athena Gtx with the FDA for Mini-medic.

Pre-market Notification Details

• Device ID: K113165
• 510k Number: K113165
• Device Name: MINI-MEDIC
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: ATHENA GTX 3620 SW 61ST STREET SUITE 395 Des Moines, IA 50321
• Contact: Sean Mahoney
• Correspondent: Sean Mahoney; ATHENA GTX 3620 SW 61ST STREET SUITE 395 Des Moines, IA 50321
• Product Code: MWI
• Subsequent Product Code: DQA
• Subsequent Product Code: DRG
• Subsequent Product Code: DRT
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-26
• Decision Date: 2012-02-02
• Summary: summary