510(k) K955891
- Device
- CARDIOVIEW TRANSTELEPHONIC SOFTWARE
- Applicant
- MICROMEDICAL, INC.
- 510(k) number
- K955891
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-08
- Date received
- 1995-12-29
- Regulation
- 870.2340
- Classification name
- Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD KEEN
- Address
- 1151 Hope St. Stamford CT US 06907 06907
FDA Registration Numbers#
- 9611295
- 3003832357
- 3003681187
- 3013298431
- 3016701404
- 3030446844
- 3014579161
- 9611045
- 1066270
- 3008457078
- 3010419931
- 3011359729
- 1450057
- 3011651230
- 3015134086
- 3045323923
- 3015142815
- 1126271
- 9611252
- 3016674095
- 3012359877
- 3023412068
- 3045498928
- 3008483389
- 3018587883
- 3010089768
- 3042928308
- 3043479346
- 3030733800
- 3010698831
- 3008820594
- 3011721071
- 3008642652
- 3004582233
- 3006371704
- 9610816
- 1220908
- 3009831876
- 3009443693
- 9610105
- 3010536822
- 3033959233
- 3007029079
- 3007384703
- 1930027
- 3008716327
- 3033558564
- 3003174284
- 3003263092
- 3031570367
- 3013500228
- 3011353843
- 3014848734
- 3021422553
- 3012027770
- 3003857828
- 3011200896
- 3005521864
- 2000004234
- 1316463
- 3018094310
- 3008729547
- 3013896610
- 3012421607
- 3001149827
- 3012404027
- 3013596024
- 3008717264
- 3031158
- 8030978
- 1218950
- 3018783526
- 3006087789
- 3009715978
- 3005569927
- 3013757696
- 3010157426
- 3023272766
- 3008881835
- 1066427
Source Documents#
Other 510(k) Records For Product Code DPS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | 2026-07-02 |
| K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2026-01-26 |
| K252361 | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | 2025-12-22 |
| K252474 | Withings BeamO (SCT02) | Withings | 2025-11-10 |
| K250569 | Cardiologs Holter Platform | Philips France Commercial | 2025-08-06 |
| K243252 | ZBPro Diagnostic | Zbeats, Inc. | 2025-07-10 |
| K243305 | Masimo W1 | Masimo Corporation | 2025-04-03 |
| K241217 | CloudHRV™ System (100-01-001) | Inmedix, Inc. | 2025-01-16 |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH | 2024-12-17 |
| K240229 | Masimo W1 | Masimo Corporation | 2024-08-08 |
| K232161 | DeepRhythm Platform | Medicalgorithmics S.A. | 2024-06-20 |
| K233266 | MEDIBLU ECG SYSTEM | Mediblu Medical, LLC | 2024-06-12 |
| K232035 | Impala | AliveCor, Inc. | 2024-06-07 |
| K232816 | Electrocardiograph, model: ECG301 | Shenzhen LE Medical Technology Co., Ltd. | 2024-06-07 |
| K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024-05-02 |
Legacy Summary#
summary
FDA Review#
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