FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEEGRAPH
K Number: K895125
·
Decision Dec 22, 1989
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
188
Applicant Total
45
Review Days
129
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Basic Information
- Device Name
- CEEGRAPH
- K Number
- K895125
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Logic Systems Corp.
- Date Received
- August 15, 1989
- Decision Date
- December 22, 1989
- 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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| K073626 | BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM | Feb 5, 2008 | Substantially Equivalent |
| K061744 | COCHLEA-SCAN / COCHLEA-SCAN PLUS | Sep 15, 2006 | Substantially Equivalent |
| K052066 | CEEGRAPH/SLEEPSCAN NETLINK TRAVELER | Aug 26, 2005 | Substantially Equivalent |
| K031352 | BIO-LOGIC INSERT EARPHONES | Jul 16, 2003 | Substantially Equivalent |
| K030907 | STACKED ABR FOR NAVIGATOR PRO | May 9, 2003 | Substantially Equivalent |
| K031009 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM | Apr 28, 2003 | Substantially Equivalent |
| K021895 | BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM | Jul 1, 2002 | Substantially Equivalent |
| K021801 | BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS | Jun 27, 2002 | Substantially Equivalent |