510(k) K243837
- Device
- iBSM
- Applicant
- Iorbit Digital Technologies Private Limited
- 510(k) number
- K243837
- Product code
- DRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-16
- Date received
- 2024-12-13
- 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
- N
Related Records
Applicant Contact
- Contact
- Sandeep Zende
- Address
- 4th Floor, Nagamma Devi Complex, Site # 22, Survey # 81/2e, Bannerghatta Main Rd. Bangalore IN 560076 560076
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
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| K211365 | Alio Medical Remote Monitoring System | Graftworx, Inc. Dba Alio | 2022-03-24 |