510(k) K791795
- Device
- COMP-ACT IV
- Applicant
- MEDCRAFT CORP.
- 510(k) number
- K791795
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-09-27
- Date received
- 1979-09-14
- Regulation
- 870.2340
- Classification name
- Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3005877899
- 3003857828
- 3031786139
- 3021422553
- 3012302888
- 3010082909
- 3010698831
- 3013500228
- 3018094310
- 1219324
- 3010390468
- 3007770164
- 1066270
- 3036039911
- 1066427
- 1218950
- 3004415095
- 3013501110
- 3008717264
- 3008729547
- 3031570367
- 3032109181
- 3009735945
- 1319390
- 3011721071
- 3009499478
- 3011651230
- 3033959233
- 3007305624
- 3005488716
- 3012528160
- 3004145393
- 3007384703
- 3010089768
- 3016931915
- 3013896610
- 9710602
- 8030978
- 3013596024
- 3009183442
- 3010419931
- 3004186703
- 3004582233
- 3006371704
- 3034603279
- 3031158
- 3003622639
- 3008820594
- 3018783526
- 1126271
- 3015134086
- 3021559257
- 9610105
- 3013757696
- 3007734888
- 3003591740
- 3014449259
- 9617277
- 3033558564
- 3011353843
- 9611252
- 3033536319
- 3009607734
- 3030154814
- 3014541700
- 3023146633
- 3016674095
- 3016852448
- 2000004234
- 3001570235
- 3011200896
- 3008716327
- 3038259592
- 3003174284
- 1930027
- 3010536822
- 3013557562
- 1220477
- 2182208
- 3045323923
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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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