Micro-Preprocessor Unit
FDA 510(k) K812914 · General Electric Co.
510(k) numberK812914
Submission
- Device name
- Micro-Preprocessor Unit
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- October 19, 1981
- Decision date
- December 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
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| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
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| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
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Questions and answers
When was Micro-Preprocessor Unit cleared by the FDA?
Micro-Preprocessor Unit (K812914) received a 510(k) decision of Substantially Equivalent on December 29, 1981, 71 days after the submission was received.
What is the product code of K812914?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.