510(k) K181270
K181270 is an FDA 510(k) premarket notification submitted by Orantech, Inc. for the device "Disposable SpO2 Sensors, Reusable SpO2 Sensors". The FDA issued a decision of Substantially Equivalent on Sep 7, 2018. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Orantech, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 7, 2018
- Date Received
- May 14, 2018
- 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)