FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUDIOTESTER SCREENING AUDIOMETER
K Number: K894484
·
Decision Jun 26, 1990
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
4
Review Days
343
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
- AUDIOTESTER SCREENING AUDIOMETER
- K Number
- K894484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Prometex, Inc.
- Date Received
- July 18, 1989
- Decision Date
- June 26, 1990
- 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