FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DAHLBERG EC BEHIND-THE-EAR HEARING AID
K Number: K853325
·
Decision Sep 23, 1985
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
23
Review Days
46
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Basic Information
- Device Name
- DAHLBERG EC BEHIND-THE-EAR HEARING AID
- K Number
- K853325
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Miracle-Ear/Dahlberg, Inc.
- Date Received
- August 8, 1985
- Decision Date
- September 23, 1985
- 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 Miracle-Ear/Dahlberg, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942893 | MIRACLE-EAR MODEL PGF + REMOTE | Aug 17, 1994 | Substantially Equivalent |
| K942895 | MIRACLE EAR MODEL PGM | Aug 17, 1994 | Substantially Equivalent |
| K942894 | MIRACLE-EAR MODEL PGC | Aug 17, 1994 | Substantially Equivalent |
| K941859 | MIRACLE-EAR EAR IMPRESSION MATERIAL | Jul 25, 1994 | Substantially Equivalent |
| K862103 | MODEL UC IN-THE-CANAL HEARING AID | Jun 23, 1986 | Substantially Equivalent |
| K862099 | DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID | Jun 23, 1986 | Substantially Equivalent |
| K862101 | MODEL UM IN-THE-CANAL HEARING AID | Jun 23, 1986 | Substantially Equivalent |
| K862104 | MODEL UC SPECTRUM IN-THE-CANAL HEARING AID | Jun 23, 1986 | Substantially Equivalent |
| K862102 | MODEL KM IN-THE-CANAL HEARING AID | Jun 23, 1986 | Substantially Equivalent |
| K862100 | MODEL ED BEHIND-THE-EAR HEARING AID | Jun 23, 1986 | Substantially Equivalent |