510(k) K780307
- Device
- CARDIAC MINIGRAPH
- Applicant
- ARCO MEDICAL PRODUCTS CO.
- 510(k) number
- K780307
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-05-19
- Date received
- 1978-02-21
- 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#
- 3031570367
- 3008457078
- 3011651230
- 3014449259
- 1054713
- 3015134086
- 3029871637
- 8030245
- 3008642652
- 3016852448
- 9611045
- 3013689228
- 3033959233
- 3014522540
- 3016674095
- 8030978
- 3015142815
- 3008293988
- 3003174284
- 3011353843
- 3043479346
- 9611252
- 3012528160
- 3010838917
- 3010698831
- 3030733800
- 3011721071
- 3003294644
- 3001149827
- 9680510
- 3008717264
- 3007048291
- 3013557562
- 3010082909
- 3034603279
- 3010342616
- 3008881835
- 3012516456
- 3042928308
- 3030446844
- 3010390468
- 3012027770
- 3013250653
- 3006371704
- 2182208
- 3010536822
- 3008729547
- 9710602
- 3009443693
- 3041276591
- 3009607734
- 2024089
- 3035371769
- 2000004234
- 3030639099
- 3004906872
- 1523530
- 3011200896
- 3014541700
- 3003832357
- 3003622639
- 3030447506
- 3011235999
- 3012250536
- 9611031
- 8030673
- 3008820594
- 2433214
- 3007384703
- 3009183442
- 3013757696
- 3014848734
- 3009499478
- 3013896610
- 3012494290
- 3018094310
- 3018783526
- 3013188547
- 3030154814
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DPS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260005 | MyoVista wavECG (DG-200-B15-003) | HeartSciences, Inc. | 2026-10-05 |
| K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | QT Medical, Inc. | 2026-09-29 |
| K254255 | S-Patch CardioAI | Wellysis Corp. | 2026-09-25 |
| 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 |
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