510(k) K151781
- Device
- Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
- Applicant
- IVY BIOMEDICAL SYSTEMS INC.
- 510(k) number
- K151781
- Product code
- DRT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-27
- Date received
- 2015-07-01
- Regulation
- 870.2300
- Classification name
- Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DICK LISTRO
- Address
- 11 Business Park Dr. Branford CT US 06405 06405
FDA Registration Numbers#
- 3008717264
- 3026751377
- 3021343210
- 3013500228
- 3014848734
- 3011790297
- 3000126629
- 3020207731
- 3012528160
- 3010536822
- 1054713
- 3016674095
- 3013679558
- 9610105
- 3013826848
- 1000122786
- 3023272766
- 3012359877
- 3019388613
- 3021559257
- 3007603826
- 3009973336
- 3015181391
- 3031158
- 3003971136
- 3016931915
- 3018783526
- 3007048291
- 3009001657
- 3029871637
- 3017812398
- 3032109181
- 3008716327
- 3009499478
- 3014541700
- 3004415095
- 3017422354
- 3012104670
- 9710602
- 3003263092
- 3006979678
- 3009607734
- 3008483389
- 3010703925
- 3005877899
- 3007413079
- 3005521864
- 3005783425
- 8030229
- 9611252
- 3003800159
- 3016592682
- 3016618143
- 3009831876
- 2221819
- 3017760831
- 9681377
- 3010390468
- 1066270
- 1319390
- 3007836437
- 3017986070
- 3015328411
- 3012238587
- 3038259592
- 3015997711
- 3016852448
- 3010698831
- 3015876
- 2080783
- 3043479346
- 3003589956
- 3014739036
- 3008460104
- 3009077524
- 3010317211
- 3015282442
- 1220908
- 3016701404
- 3003294644
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DRT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261286 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-05-20 |
| K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-02-03 |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | 2026-01-28 |
| K251364 | Sleepiz One+ (2.5) | Sleepiz AG | 2025-07-29 |
| K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | 2024-05-30 |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | Murata Vios, Inc. | 2024-03-22 |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2024-02-09 |
| K223163 | Sleepiz One+ | Sleepiz AG | 2023-08-18 |
| K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2022-09-28 |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021-04-26 |
| K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 |
| K172586 | Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | 2018-06-22 |
| K170828 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2017-05-17 |
| K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015-12-16 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases