510(k) K171423
K171423 is an FDA 510(k) premarket notification submitted by Xhale, Inc. for the device "Nasal Alar SpO2 Sensor". The FDA issued a decision of Substantially Equivalent on Jul 27, 2017. 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
- Jul 27, 2017
- Date Received
- May 15, 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)