Medelec 2110 and 2114 EEG
FDA 510(k) K922548 · Medelec Intl. Corp.
510(k) numberK922548
Submission
- Device name
- Medelec 2110 and 2114 EEG
- Applicant
- Medelec Intl. Corp.
England, GB - Received
- June 1, 1992
- Decision date
- November 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K865106 | Prophylactic (Condom) Mr. JohnnyHIS · Traditional | 05/20/1987SE |
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| K854622 | Prophylactic (Condom)HIS · Traditional | 04/11/1986SE |
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Questions and answers
When was Medelec 2110 and 2114 EEG cleared by the FDA?
Medelec 2110 and 2114 EEG (K922548) received a 510(k) decision of Substantially Equivalent on November 3, 1992, 155 days after the submission was received.
What is the product code of K922548?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.