FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GSI Corti
K Number: K180287
·
Decision May 11, 2018
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
16
Review Days
99
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
- GSI Corti
- K Number
- K180287
- 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
- Grason-Stadler, Inc.
- Date Received
- February 1, 2018
- Decision Date
- May 11, 2018
- 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
Sera
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Grason-Stadler, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K172403 | GSI Novus | Oct 20, 2017 | Substantially Equivalent |
| K000097 | GSI 2000 MIDDLE EAR ANALYZER | Apr 12, 2000 | Substantially Equivalent |
| K974237 | GSI 70 AUDIOPATH SCREENER | Feb 10, 1998 | Substantially Equivalent |
| K970324 | GSI SA60 DPOAE SYSTEM | Jun 6, 1997 | Substantially Equivalent |
| K953684 | GSI 61 CLINICAL AUDIOMETER | Oct 27, 1995 | Substantially Equivalent |
| K951759 | GSI 65 COMPUTERIZED AUDIOMETER | Jul 6, 1995 | Substantially Equivalent |
| K902540 | GSI 17 SCREENING AUDIOMETER | Jul 13, 1990 | Substantially Equivalent |
| K890124 | ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER | Jul 14, 1989 | Substantially Equivalent |
| K870030 | THE SCREENER GSI 55 ABR SCREENER | Mar 13, 1987 | Substantially Equivalent |
| K863353 | MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) | Nov 3, 1986 | Substantially Equivalent |