DistaSense(TM) (v1)
Life Detection Technologies · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Sunnyvale
- Advisory committee description
- Cardiovascular
- Address 1
- 440 N Wolfe Rd.
- Address 2
- Suite Wl 265
- Statement or summary
- Summary
- Product code
- DRT
- Zip code
- 94085
- Applicant
- Life Detection Technologies
- Decision date
- 2026-09-25
- Decision code
- SESE
- Country code
- US
- Device name
- DistaSense(TM) (v1)
- Advisory committee
- CV
- Contact
- Peter Rule
- K number
- K254058
- State
- CA
- Date received
- 2025-12-17
- Review advisory committee
- CV
- Postal code
- 94085
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.2300
- Device class
- 2
- Registration number
- 9610105, 3016931915, 1219324, 1319390, 3005877899, 3017760831, 3003294644, 3009001657, 3012238587, 3010390468, 3023272766, 8030229, 3013679558, 3029871637, 3006979678, 9611031, 1066270, 3014739036, 3017986070, 3021559257, 3043479346, 3003263092, 3010703925, 3013596024, 3013826848, 3009973336, 3016852448, 3003589956, 3009673645, 3014579161, 1221108, 9610816, 3000126629, 3011790297, 3001570235, 3031158, 1220908, 1218950, 3008483389, 9710654 +64 more
- FEI number
- 1000114111, 3003513129, 3016931915, 1219324, 3002807720, 1319390, 3005877899, 3017760831, 3003294644, 3009001657, 3012238587, 3010390468, 3023272766, 3002807167, 1000300598, 3013679558, 3029871637, 3006979678, 3002807739, 3014739036, 3017986070, 3021559257, 3043479346, 3003263092, 3010703925, 3013596024, 3013826848, 3009973336, 3016852448, 3003589956, 3009673645, 3014579161, 1221108, 3000126629, 3011790297, 3001570235, 1220908, 1218950, 3008483389, 3005521864 +64 more