510(k) K241086
K241086 is an FDA 510(k) premarket notification submitted by Avidhrt, Inc. for the device "Avidhrt Sense SpO2". The FDA issued a decision of Substantially Equivalent on May 9, 2025. 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
- May 9, 2025
- Date Received
- April 19, 2024
- 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