510(k) K241397
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 2024
- Date Received
- May 16, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type