510(k) K183556
K183556 is an FDA 510(k) premarket notification submitted by Taiwan Biophotonic Corporation for the device "oCare Wrist Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on Feb 15, 2019. 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
- Feb 15, 2019
- Date Received
- Dec 20, 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)