510(k) K173045
K173045 is an FDA 510(k) premarket notification submitted by Shenzhen Greatmade Tech Limited for the device "Oximeter". The FDA issued a decision of Substantially Equivalent on Jun 5, 2018. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 5, 2018
- Date Received
- Sep 28, 2017
- Clearance Type
- Traditional
- 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
- 510(k)