FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BELTONE PERSONAL HEARING SCREENER
K Number: K943616
·
Decision Jul 12, 1995
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
42
Review Days
350
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
- BELTONE PERSONAL HEARING SCREENER
- K Number
- K943616
- 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
- Beltone Electronics Corp.
- Date Received
- July 27, 1994
- Decision Date
- July 12, 1995
- 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 Beltone Electronics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K971852 | AIR CONDUCTION HAEARING AIDS | Aug 15, 1997 | Substantially Equivalent |
| K963958 | IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT | Dec 5, 1996 | Substantially Equivalent |
| K955930 | BELTONE COMPOSER 2000 BTE HP | Mar 1, 1996 | Substantially Equivalent |
| K954936 | BELTONE ULTIMA 80 OTOSONIC POWER PAS | Dec 6, 1995 | Substantially Equivalent |
| K951587 | BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K | Jun 30, 1995 | Substantially Equivalent |
| K950868 | BELTONE COMPOSER 2000 | Jun 28, 1995 | Substantially Equivalent |
| K952097 | OTOSONIC (OSI) CF 10-K, 10-D | Jun 28, 1995 | Substantially Equivalent |
| K946340 | BELTONE COMPARAFIT | Apr 13, 1995 | Substantially Equivalent |
| K944502 | BELTONE CONCERTO S | Oct 20, 1994 | Substantially Equivalent |
| K942716 | AUDIO EXPERT AUDIOMETER | Sep 2, 1994 | Substantially Equivalent |