510(k) K223163
K223163 is an FDA 510(k) premarket notification submitted by Sleepiz AG for the device "Sleepiz One+". The FDA issued a decision of Substantially Equivalent on August 18, 2023. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Sleepiz AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2023
- Date Received
- October 7, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type