FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K Number: K073626
·
Decision Feb 5, 2008
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
45
Review Days
41
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Basic Information
- Device Name
- BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
- K Number
- K073626
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Logic Systems Corp.
- Date Received
- December 26, 2007
- Decision Date
- February 5, 2008
- Product Code
- GWJ
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Bio-Logic Systems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Nov 1, 2012 | Substantially Equivalent |
| K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | Jul 26, 2012 | 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 |
| K021215 | BIO-LOGIC ABAER CUB | May 15, 2002 | Substantially Equivalent |