FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE
K Number: K844015
·
Decision Dec 17, 1984
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
14
Review Days
66
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Basic Information
- Device Name
- CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE
- K Number
- K844015
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1420
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Cns, Inc.
- Date Received
- October 12, 1984
- Decision Date
- December 17, 1984
- Product Code
- GWS
- 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 |
|---|---|---|---|
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | FDA class 1 | Neurology |
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Other Clearances by Cns, Inc.
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|---|---|---|---|
| K955711 | BREATHE RIGHT NASAL STRIP | May 30, 1996 | Substantially Equivalent |
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| K953772 | BREATHE RIGHT NASAL STRIP | Oct 20, 1995 | Substantially Equivalent |
| K950273 | SLEEP TEST(TM) | Sep 19, 1995 | Substantially Equivalent |
| K921220 | BREATHE RIGHT | Oct 7, 1993 | Substantially Equivalent |
| K912436 | AM-PAK | Oct 18, 1991 | Substantially Equivalent |
| K904432 | SLEEP I/T-5 AND SLEEP I/T-8 | Jul 10, 1991 | Substantially Equivalent |
| K910452 | RESPI-PAK RT-PAK | Apr 16, 1991 | Substantially Equivalent |
| K901549 | CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. | Oct 24, 1990 | Substantially Equivalent |
| K897107 | POLY G PHYSIOLOGICAL DATA RECORDER | Mar 12, 1990 | Substantially Equivalent |