FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 1220, OR E-NET (54-62 CM)
K Number: K961609
·
Decision May 10, 1996
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
22
Review Days
15
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Basic Information
- Device Name
- MODEL 1220, OR E-NET (54-62 CM)
- K Number
- K961609
- 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
- April 25, 1996
- Decision Date
- May 10, 1996
- 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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|---|---|---|---|
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| K020670 | MODEL 4310 PSARRAY2 EEG ELECTRODE | Oct 8, 2002 | Substantially Equivalent |
| K020671 | PSA4000 EEG MONITOR WITH FRONTAL PSI | Oct 4, 2002 | Substantially Equivalent |
| K001069 | MODEL 4000 EEG MONITOR WITH PSI (PSA4000) | Jun 30, 2000 | Substantially Equivalent |
| K001055 | MODEL 4300 PSARRAY EEG ELECTRODE SET | May 11, 2000 | Substantially Equivalent |
| K970942 | MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM | Jun 2, 1997 | Substantially Equivalent |
| K970694 | MODEL 1700, HYDRO PREP | May 14, 1997 | Substantially Equivalent |
| K962447 | EQUINOX DIGITAL EEG SYSTEM | Dec 12, 1996 | Substantially Equivalent |
| K962157 | MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM | Nov 25, 1996 | Substantially Equivalent |