FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-LOGIC INSERT EARPHONES
K Number: K031352
·
Decision Jul 16, 2003
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
45
Review Days
78
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIO-LOGIC INSERT EARPHONES
- K Number
- K031352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Logic Systems Corp.
- Date Received
- April 29, 2003
- Decision Date
- July 16, 2003
- Product Code
- EWO
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EWO), ordered by most recent decision date.
OtoNova/OtoNova Pro
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Otoport Pro
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
hearOAE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Lyra
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GSI Corti
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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 |
| 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 |
| 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 |