Model 1207, Hydrodot Neuromonitoring System Adhesive Pads
FDA 510(k) K953449 · Physiometrix, Inc.
510(k) numberK953449
Submission
- Device name
- Model 1207, Hydrodot Neuromonitoring System Adhesive Pads
- Applicant
- Physiometrix, Inc.
North Billerica, MA, US - Received
- July 18, 1995
- Decision date
- October 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K970942 | Model 1320, Neurolink II Neuromonitoring SystemGWQ · Traditional | 06/02/1997SE |
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| K962447 | Equinox Digital EEG SystemGWQ · Traditional | 12/12/1996SE |
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Questions and answers
When was Model 1207, Hydrodot Neuromonitoring System Adhesive Pads cleared by the FDA?
Model 1207, Hydrodot Neuromonitoring System Adhesive Pads (K953449) received a 510(k) decision of Substantially Equivalent on October 12, 1995, 86 days after the submission was received.
What is the product code of K953449?
The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.