FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
K Number: K893432
·
Decision Aug 4, 1989
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
73
Review Days
94
Basic Information
- Device Name
- PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
- K Number
- K893432
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- ELECTONE, INC.
- Date Received
- May 2, 1989
- Decision Date
- August 4, 1989
- 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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|---|---|---|---|
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| K953054 | AM 260 OHM | Aug 15, 1995 | Substantially Equivalent |
| K953052 | AM 260 K-AMP | Aug 15, 1995 | Substantially Equivalent |
| K953053 | AM 260 PP | Aug 15, 1995 | Substantially Equivalent |
| K953049 | Z24 | Aug 15, 1995 | Substantially Equivalent |
| K953051 | Z35 | Aug 15, 1995 | Substantially Equivalent |