510(k) K132803
- Device
- MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
- Applicant
- MEDAPPS INC., DBA ALERE CONNECT
- 510(k) number
- K132803
- Product code
- DRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-12
- Date received
- 2013-09-06
- Regulation
- 870.2910
- Classification name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENT DICKS
- Address
- 8767 E. Via De Ventura, Suite 300 Scottsdale AZ US 85258 85258
FDA Registration Numbers#
- 3008717264
- 3007134734
- 3004748528
- 3017643152
- 3014640930
- 3025330366
- 2134265
- 2184149
- 3015455735
- 3004091615
- 3013319763
- 3013500228
- 3014848734
- 3000126629
- 3012528160
- 3010536822
- 3026960443
- 3044675072
- 3012606445
- 3008114669
- 9610105
- 3004111573
- 3012359877
- 1054811
- 2024168
- 3033715634
- 3014886121
- 1523530
- 3021559257
- 3007603826
- 3004145393
- 3008058132
- 2124215
- 3027510187
- 3015181391
- 1930027
- 3005334138
- 3003971136
- 3014856521
- 3015907115
- 3008101184
- 3004727197
- 3009896984
- 3021988268
- 3007048291
- 1000548922
- 1223925
- 1319639
- 3009499478
- 3014541700
- 3015529350
- 3029904429
- 3004091281
- 3003263092
- 3013791928
- 3019737388
- 3010703925
- 3018188848
- 3042272797
- 1713468
- 8020045
- 3010552191
- 3007413079
- 8030229
- 9611252
- 3016592682
- 3017446092
- 3016618143
- 3013896610
- 3031841433
- 9681377
- 2221819
- 3003982635
- 3009735945
- 3011651103
- 2133928
- 2029275
- 1063285
- 3012302888
Source Documents#
Other 510(k) Records For Product Code DRG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026-01-22 |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025-10-02 |
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025-06-04 |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025-05-16 |
| K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024-11-12 |
| 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 |
| K220526 | HD+12, HD+15 | Cardioline S.P.A | 2023-05-15 |
| 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 |
Legacy Summary#
summary
FDA Review#
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