510(k) clearance
DistaSense(TM) (v1)
- 510(k) number
- K254058
- Applicant
- Life Detection Technologies
- Decision date
- Sep 25, 2026
- Date received
- Dec 17, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DRT
- Device type
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II
- Regulation
- 21 CFR 870.2300
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Sunnyvale, CA, US