510(k) K240305
K240305 is an FDA 510(k) premarket notification submitted by Sibel Health, Inc. for the device "ANNE Limb". The FDA issued a decision of Substantially Equivalent on May 28, 2024. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Sibel Health, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2024
- Date Received
- February 2, 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