Neurolink Ip Model: PK1117
FDA 510(k) K100683 · Natus Medical Incorporated
510(k) numberK100683
Submission
- Device name
- Neurolink Ip Model: PK1117
- Applicant
- Natus Medical Incorporated
Oakville, Ontario, CA - Received
- March 10, 2010
- Decision date
- April 9, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Neurolink Ip Model: PK1117 cleared by the FDA?
Neurolink Ip Model: PK1117 (K100683) received a 510(k) decision of Substantially Equivalent on April 9, 2010, 30 days after the submission was received.
What is the product code of K100683?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.