WARD-CSS (v1.2.x)
Ward 24/7 Aps · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Copenhagen
- Advisory committee description
- Cardiovascular
- Address 1
- Health Tech Hub Copenhagen, Danneskiold-Samsøes Allé 41
- Address 2
- 1434 København K
- Statement or summary
- Summary
- Product code
- MWI
- Applicant
- Ward 24/7 Aps
- Decision date
- 2025-02-14
- Decision code
- SESE
- Country code
- DK
- Device name
- WARD-CSS (v1.2.x)
- Advisory committee
- CV
- Contact
- Madolina Christian
- K number
- K241958
- Date received
- 2024-07-03
- Review advisory committee
- CV
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.2300
- Device class
- 2
- Registration number
- 3033959233, 3018094310, 3010399798, 9611348, 3013298431, 3008729547, 1222630, 3008716327, 3003768277, 3003589956, 3009499478, 3010824458, 3007134734, 3007137598, 3012103976, 3016852448, 3003681187, 3021632375, 3035111606, 1054713, 3010390468, 2027454, 3016674095, 3007029079, 3008977358, 3009156722, 3004009431, 3007413079, 3016618143, 3011651230, 3012359877, 3005569927, 3013896610, 3014856521, 1066427, 8040564, 3006606827, 3043543260, 3042175844, 3004091281 +136 more
- FEI number
- 3033959233, 3018094310, 3010399798, 3013298431, 3008729547, 3008716327, 3003589956, 3009499478, 3010824458, 1000292048, 3007134734, 3007137598, 3012103976, 3016852448, 3003681187, 3021632375, 3035111606, 3010390468, 3000957797, 2027454, 3016674095, 3007029079, 3008977358, 3009156722, 3004009431, 3007413079, 3016618143, 3011651230, 3012359877, 3005569927, 3013896610, 3014856521, 3006606827, 3043543260, 3042175844, 3027256461, 2221819, 3004188066, 3003971136, 3006254866 +136 more