FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID
K Number: K880223
·
Decision Mar 14, 1988
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
12
Review Days
54
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Basic Information
- Device Name
- MAGIC EAR MODEL MB BEHIND-THE-EAR HEARING AID
- K Number
- K880223
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Audiotone, Inc.
- Date Received
- January 20, 1988
- Decision Date
- March 14, 1988
- 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 Audiotone, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881653 | AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID | May 13, 1988 | Substantially Equivalent |
| K881738 | AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID | May 13, 1988 | Substantially Equivalent |
| K881737 | AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID | May 13, 1988 | Substantially Equivalent |
| K881652 | AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID | May 11, 1988 | Substantially Equivalent |
| K880225 | MAGIC EAR MODEL CI IN-THE-EAR HEARING AID | Mar 9, 1988 | Substantially Equivalent |
| K880224 | MAGIC EAR MODEL MC BEHIND-THE-EAR HEARING AID | Mar 7, 1988 | Substantially Equivalent |
| K874384 | AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID | Jan 19, 1988 | Substantially Equivalent |
| K874385 | AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID | Jan 7, 1988 | Substantially Equivalent |
| K874323 | MODEL A-70, BEHIND-THE-EAR HEARING AID | Nov 20, 1987 | Substantially Equivalent |
| K874324 | MODEL A-17, BEHIND-THE-EAR HEARING AID | Nov 16, 1987 | Substantially Equivalent |