Mingograf EEG21
FDA 510(k) K802292 · Siemens Corp.
510(k) numberK802292
Submission
- Device name
- Mingograf EEG21
- Applicant
- Siemens Corp.
Walker, MI, US - Received
- September 19, 1980
- Decision date
- October 3, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GWQ – Full-Montage Standard Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
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Questions and answers
When was Mingograf EEG21 cleared by the FDA?
Mingograf EEG21 (K802292) received a 510(k) decision of Substantially Equivalent on October 3, 1980, 14 days after the submission was received.
What is the product code of K802292?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.