FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUDIONICS PB MAX HEARING AID
K Number: K800269
·
Decision Feb 26, 1980
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
2
Review Days
20
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Basic Information
- Device Name
- AUDIONICS PB MAX HEARING AID
- K Number
- K800269
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Audionics Corp.
- Date Received
- February 6, 1980
- Decision Date
- February 26, 1980
- 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 Audionics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K800940 | AUDIONICS PB MAX HEARING AID | Jun 4, 1980 | Substantially Equivalent |