510(k) K102206
- Device
- ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
- Applicant
- MORTARA INSTRUMENT, INC.
- 510(k) number
- K102206
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-02-18
- Date received
- 2010-08-05
- Regulation
- 870.2340
- Classification name
- Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES MORREALE
- Address
- 7865 N. 86th St. Milwaukee WI US 53224 53224
FDA Registration Numbers#
- 1523530
- 3003263092
- 3033959233
- 3008457078
- 3030446844
- 3018094310
- 3003647588
- 3004035727
- 3013298431
- 3008729547
- 1319390
- 9680510
- 3006087789
- 3008716327
- 3018587883
- 9611031
- 3009499478
- 3020981894
- 8030245
- 3012302888
- 3007134734
- 1314417
- 3011861727
- 3003681187
- 3016852448
- 1054713
- 3007048291
- 3010390468
- 3016674095
- 3043226252
- 3007029079
- 9611045
- 3014541700
- 3007413079
- 3016618143
- 3010342616
- 3011651230
- 3012359877
- 3003622639
- 3005569927
- 3013896610
- 3013679558
- 1066427
- 3008293988
- 3014449259
- 3005488716
- 3013684844
- 3014848734
- 9610816
- 3007384703
- 3010698831
- 3003971136
- 3004415095
- 2000004234
- 3015142815
- 3012421607
- 3008483389
- 3023146633
- 3030733800
- 2080783
- 3013757696
- 3007305624
- 3009183442
- 3011359729
- 3005521864
- 3004186703
- 3000126629
- 3010536822
- 3007770164
- 3003294644
- 3011235999
- 3013596024
- 3003591740
- 2024089
- 3010082909
- 1218950
- 3008642652
- 3011721071
- 3011200896
Source Documents#
Other 510(k) Records For Product Code DPS #
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|---|---|---|---|
| K260640 | Kinetic Software Library | Monebo Technologies, Inc. | 2026-10-23 |
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| K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | QT Medical, Inc. | 2026-09-29 |
| 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#
summary
FDA Review#
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