FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE
K Number: K946318
·
Decision Apr 24, 1995
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
426
Applicant Total
22
Review Days
117
Basic Information
- Device Name
- MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE
- K Number
- K946318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHYSIOMETRIX, INC.
- Date Received
- December 28, 1994
- Decision Date
- April 24, 1995
- Product Code
- GXY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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