510(k) K160582
K160582 is an FDA 510(k) premarket notification submitted by Athena Gtx for the device "WiCap". The FDA issued a decision of Substantially Equivalent on September 2, 2016. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Athena Gtx has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2016
- Date Received
- March 1, 2016
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type