510(k) K262447
K262447 is an FDA 510(k) premarket notification submitted by Circadia Health, Inc. for the device "The Circadia CX00 System (CX00)". The FDA issued a decision of Substantially Equivalent on Oct 15, 2026. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Circadia Health, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 15, 2026
- Date Received
- Jul 16, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
- 510(k)