510(k) K173203
K173203 is an FDA 510(k) premarket notification submitted by Athena Gtx for the device "Athena GTX Device Management Suite (ADMS) Software". The FDA issued a decision of Substantially Equivalent on March 14, 2018. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Athena Gtx has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2018
- Date Received
- October 2, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type