FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP
K Number: K940099
·
Decision Apr 1, 1994
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
42
Review Days
81
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Basic Information
- Device Name
- OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP
- K Number
- K940099
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beltone Electronics Corp.
- Date Received
- January 10, 1994
- Decision Date
- April 1, 1994
- Product Code
- ESD
- 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | FDA class 1 | Ear, Nose, Throat |
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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 |
| K943616 | BELTONE PERSONAL HEARING SCREENER | Jul 12, 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 |