FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
155 PP AGC-I
K Number: K940608
·
Decision May 4, 1994
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
26
Review Days
79
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Basic Information
- Device Name
- 155 PP AGC-I
- K Number
- K940608
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Danavox, Inc.
- Date Received
- February 14, 1994
- Decision Date
- May 4, 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 Danavox, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K851069 | BODY TYPE HEARING AID 107S | Jun 5, 1985 | Substantially Equivalent |
| K843791 | BEHIND-THE-EAR 123 VTH | Nov 9, 1984 | Substantially Equivalent |
| K833486 | IN-THE-EAR HEARING AID MODEL | Jun 22, 1984 | Substantially Equivalent |
| K832326 | BEHIND-THE-EAR #123 AGCI | Sep 29, 1983 | Substantially Equivalent |
| K832751 | BEHIND-THE-EAR SERIES 125 | Sep 29, 1983 | Substantially Equivalent |
| K823073 | 101M IN-THE-EAR | Jan 7, 1983 | Substantially Equivalent |
| K823531 | BEHIND-THE-EAR HEARING AID #8003 | Dec 15, 1982 | Substantially Equivalent |
| K822619 | BEHIND-THE-EAR MODEL 115PPPCW | Sep 14, 1982 | Substantially Equivalent |
| K822655 | BEHIND-THE-EAR MODEL 115 V AGC O W | Sep 14, 1982 | Substantially Equivalent |
| K822387 | BEHIND-THE-EAR MODEL SERIES 123 | Aug 19, 1982 | Substantially Equivalent |