510(k) K254058
K254058 is an FDA 510(k) premarket notification submitted by Life Detection Technologies for the device "DistaSense(TM) (v1)". The FDA issued a decision of Substantially Equivalent on Sep 25, 2026. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 25, 2026
- Date Received
- Dec 17, 2025
- 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)