510(k) K143216
K143216 is an FDA 510(k) premarket notification submitted by Xhale, Inc. for the device "Assurance Alar / Nasal SpO2 Sensor". The FDA issued a decision of Substantially Equivalent on Mar 17, 2015. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Xhale, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 17, 2015
- Date Received
- Nov 10, 2014
- 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)