510(k) K210032
K210032 is an FDA 510(k) premarket notification submitted by Leadtek Research, Inc. for the device "Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)". The FDA issued a decision of Substantially Equivalent on Sep 1, 2021. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Leadtek Research, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 1, 2021
- Date Received
- Jan 5, 2021
- Clearance Type
- Special
- 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)