Monitor, Portable, Patient, G.E.
FDA 510(k) K770760 · General Electric Co.
510(k) numberK770760
Submission
- Device name
- Monitor, Portable, Patient, G.E.
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- April 25, 1977
- Decision date
- May 6, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| 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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| K103489 | GE Veo Reconstruction OptionJAK · Traditional | 09/09/2011SE |
| K082317 | GE Lunar Frax 10-YEAR Fracture Risk Software OptionKGI · Traditional | 09/26/2008SE |
| K081921 | GE Vivid E9 UltrasoundIYN · Special | 08/06/2008SE |
| K073297 | GE Logiq P6IYN · Special | 12/18/2007SE |
| K072952 | GE EchopacLLZ · Special | 11/16/2007SE |
| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
| K071985 | GE Vivid S5 and S6 Diagnostic UltrasoundIYN · Special | 08/17/2007SE |
Questions and answers
When was Monitor, Portable, Patient, G.E. cleared by the FDA?
Monitor, Portable, Patient, G.E. (K770760) received a 510(k) decision of Substantially Equivalent on May 6, 1977, 11 days after the submission was received.
What is the product code of K770760?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.