510(k) K220526
- Device
- HD+12, HD+15
- Applicant
- Cardioline S.P.A
- 510(k) number
- K220526
- Product code
- DRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-15
- Date received
- 2022-02-24
- Regulation
- 870.2910
- Classification name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Antonella Bornacin
- Address
- Via Linz 151 Trento IT 38121 38121
FDA Registration Numbers#
- 3015181391
- 1000548922
- 3011651103
- 2029275
- 3014541700
- 3013501110
- 3033118181
- 3013783488
- 3031841433
- 3003832357
- 3009499478
- 3014856521
- 3017986070
- 3009503584
- 3009600098
- 3015529350
- 3029904429
- 3044675072
- 3033715634
- 9681377
- 3010698831
- 3012302888
- 3030154814
- 1319639
- 3004091281
- 3043479346
- 1523530
- 3006240053
- 2183613
- 3006948155
- 3013596024
- 1721686
- 3013500228
- 9610816
- 9680215
- 3010703925
- 3015134004
- 3004727197
- 1063285
- 3014848734
- 3025330366
- 2124215
- 3008058132
- 3013791928
- 3004111573
- 3016852448
- 3012606445
- 1033601
- 3026960443
- 3008460104
- 8020045
- 3003263092
- 3021988268
- 3007413079
- 3007603826
- 2134265
- 3007134734
- 3008717264
- 3004748528
- 2134285
- 1320894
- 3012359877
- 3018188848
- 1054811
- 1651104
- 3027510187
- 3003971136
- 3015328411
- 3009077524
- 3016618143
- 3004485927
- 3013319763
- 3009896984
- 3021559257
- 3017446092
- 3014886121
- 3010536822
- 1218950
- 9611252
Source Documents#
Other 510(k) Records For Product Code DRG#
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|---|---|---|---|
| K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026-01-22 |
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| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025-06-04 |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025-05-16 |
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| K241101 | BioButton System | Biointellisense, Inc. | 2024-09-26 |
| K240251 | ANNE Chest | Sibel Health, Inc. | 2024-06-03 |
| K223711 | ANNE One | Sibel Health, Inc. | 2023-08-10 |
| K223073 | Alio | Alio, Inc. | 2023-03-17 |
| K222398 | Care Team Portal | Vivify Health, Inc. | 2023-02-06 |
| K212957 | BioButton System | Biolntellisense, Inc. | 2022-12-12 |
| K221530 | ANNE Pediatric | Sibel, Inc. | 2022-11-22 |
| K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022-07-15 |
| K213233 | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | 2022-06-23 |
| K211365 | Alio Medical Remote Monitoring System | Graftworx, Inc. Dba Alio | 2022-03-24 |