FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.
K Number: K901549
·
Decision Oct 24, 1990
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
14
Review Days
204
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Basic Information
- Device Name
- CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.
- K Number
- K901549
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Cns, Inc.
- Date Received
- April 3, 1990
- Decision Date
- October 24, 1990
- 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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| 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 |
| K897107 | POLY G PHYSIOLOGICAL DATA RECORDER | Mar 12, 1990 | Substantially Equivalent |
| K860829 | CNS 4/8 AND CT 48.1 SOFTWARE | May 29, 1986 | Substantially Equivalent |