510(k) K142468
- Device
- Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System
- Applicant
- CARDIAC INSIGHT, INC.
- 510(k) number
- K142468
- Product code
- DSH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-11
- Date received
- 2014-09-03
- Regulation
- 870.2800
- Classification name
- Recorder, Magnetic Tape, Medical
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRAD HARLOW
- Address
- 2815 Eastlake Ave. E., Suite 300 Seattle WA US 98102 98102
FDA Registration Numbers#
- 3010381606
- 2017865
- 3003971136
- 8030978
- 3014226707
- 3009077524
- 2132111
- 3003584029
- 3007663004
- 3007208829
- 3006258337
- 9680510
- 3016701404
- 1316463
- 3012032144
- 3013500228
- 3042167640
- 3014848734
- 1218950
- 3012528160
- 3000126629
- 3014235520
- 3016618143
- 3021332567
- 9610816
- 3030721635
- 3014111150
- 3014522540
- 3029915537
- 3007184699
- 3021769057
- 3009499478
- 3010082909
- 3004009431
- 3010576710
- 3024821700
- 3013596024
- 3013889955
- 1527715
- 3010342616
- 3006087789
- 3003263092
- 3008773647
- 3006733253
- 2133409
- 3004035727
- 3002808458
- 3030310221
- 3024673
- 3014929383
- 3005737664
- 3008505660
- 3014271754
- 3043479346
- 3016812424
- 3026042935
Source Documents#
Other 510(k) Records For Product Code DSH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | 2026-04-23 |
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | 2025-12-03 |
| K243650 | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | 2025-08-15 |
| K243603 | AeviceMD | Aevice Health Pte. , Ltd. | 2025-05-05 |
| K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | 2025-05-02 |
| K232670 | HiCardi+ H100 | MEZOO Co., Ltd. | 2024-09-20 |
| K233906 | S-Patch (S-Patch ExL) | Wellysis Corp. | 2024-02-16 |
| K231104 | ABPMpro | Somnomedics GmbH | 2023-11-27 |
| K233110 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2023-11-22 |
| K230184 | Holter ECG and ABP System | Edan Instruments, Inc. | 2023-09-25 |
| K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | 2023-08-30 |
| K223382 | AeviceMD | Aevice Health Pte. , Ltd. | 2023-07-07 |
| K223049 | CardioSTAT® ECG Test Solution | Icentia, Inc. | 2023-03-22 |
| K214073 | eWave Monitor | Wearlinq, Inc. | 2022-10-20 |
| K203638 | AT-Patch ECG Analysis System | Atsens Co., Ltd. | 2022-10-12 |
Legacy Summary#
summary
FDA Review#
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