FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROTRAC
K Number: K823116
·
Decision Dec 7, 1982
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
17
Review Days
47
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Basic Information
- Device Name
- NEUROTRAC
- K Number
- K823116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Interspec, Inc.
- Date Received
- October 21, 1982
- Decision Date
- December 7, 1982
- Product Code
- GWQ
- 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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | FDA class 2 | Neurology |
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|---|---|---|---|
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| K924231 | INTERSPEC APOGEE CLA | Jun 14, 1993 | Substantially Equivalent |
| K915696 | INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE | Nov 24, 1992 | Substantially Equivalent |
| K920678 | ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER | Apr 2, 1992 | Substantially Equivalent |
| K911073 | PROBE REFILL KIT | Jun 6, 1991 | Substantially Equivalent |
| K910049 | INTERSPEC APOGEE, MODIFICATION | Apr 29, 1991 | Substantially Equivalent |
| K903839 | INTERSPEC APOGEE | Nov 16, 1990 | Substantially Equivalent |
| K900155 | INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER | Oct 5, 1990 | Substantially Equivalent |
| K892944 | INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 | Jul 19, 1989 | Substantially Equivalent |
| K890173 | INTERSPEC APOGEE | Apr 14, 1989 | Substantially Equivalent |