Telemetry Monitor (iT30, iT50)
Edan Instruments, Inc. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Shenzhen
- Advisory committee description
- Cardiovascular
- Address 1
- 15 Jinhui Rd., Jinsha Community, Kengzi Sub-District,
- Address 2
- Pingshan District,
- Statement or summary
- Summary
- Product code
- MHX
- Zip code
- 518122
- Applicant
- Edan Instruments, Inc.
- Decision date
- 2026-08-06
- Decision code
- SESE
- Country code
- CN
- Device name
- Telemetry Monitor (iT30, iT50)
- Advisory committee
- CV
- Contact
- Tracy Yue
- K number
- K251508
- Date received
- 2025-05-16
- Review advisory committee
- CV
- Postal code
- 518122
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1025
- Device class
- 2
- Registration number
- 3009443693, 1316463, 8022257, 3010536822, 3019545235, 3006606827, 3030597679, 8030978, 3012238587, 3011353843, 3001570235, 3009673645, 3012972516, 3021736577, 9610105, 3004415095, 3011120183, 3013679558, 3020115, 3007836437, 3004196561, 1218950, 3003263092, 3007481893, 3013596024, 3021219789, 3010611950, 3021559257, 3005521864, 3003589956, 3004526608, 3030446844, 3003971136, 3008363989, 3008642652, 3010882708, 3007413079, 3022123357, 3007305624, 2032233 +80 more
- FEI number
- 3009443693, 1316463, 3010536822, 3019545235, 3006606827, 3030597679, 3012238587, 3011353843, 3001570235, 3009673645, 3012972516, 3021736577, 3004415095, 3011120183, 3013679558, 3020115, 3007836437, 3004196561, 3000957797, 1218950, 3003263092, 3007481893, 3013596024, 3021219789, 3010611950, 3021559257, 3005521864, 3003589956, 3004526608, 3030446844, 3003971136, 3008363989, 3008642652, 3010882708, 3003757840, 3007413079, 3007305624, 3006147705, 3004977335, 3013501110 +80 more