Mortara Eli 10 Electrocardiograph
FDA 510(k) K070539 · Mortara Instrument, Inc.
510(k) numberK070539
Submission
- Device name
- Mortara Eli 10 Electrocardiograph
- Applicant
- Mortara Instrument, Inc.
Milwaukee, WI, US - Received
- February 26, 2007
- Decision date
- March 15, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
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| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
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| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsDPS · Traditional | 01/06/2016SE |
| K141020 | Surveyor S4 Mobile MonitorDRG · Traditional | 12/03/2014SE |
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Questions and answers
When was Mortara Eli 10 Electrocardiograph cleared by the FDA?
Mortara Eli 10 Electrocardiograph (K070539) received a 510(k) decision of Substantially Equivalent on March 15, 2007, 17 days after the submission was received.
What is the product code of K070539?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.