FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHARP II HELIX HEARING AID
K Number: K941295
·
Decision Jun 17, 1994
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
65
Review Days
92
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Basic Information
- Device Name
- SHARP II HELIX HEARING AID
- K Number
- K941295
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Miracle-Ear, Inc.
- Date Received
- March 17, 1994
- Decision Date
- June 17, 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 Miracle-Ear, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972346 | MIRACLE-EAR ITE DIGITAL | Jul 23, 1997 | Substantially Equivalent |
| K972344 | MIRACLE-EAR DIGITAL BTE | Jul 23, 1997 | Substantially Equivalent |
| K972345 | DAHLBERG/MIRACLE-EAR | Jul 23, 1997 | Substantially Equivalent |
| K970262 | MULTI-CHANNEL COMPRESSION BTE (SD) | Mar 31, 1997 | Substantially Equivalent |
| K964419 | MIRACLE - EAR (ITE/ITC/CIC) | Feb 4, 1997 | Substantially Equivalent |
| K965057 | AUDIOTONE (A554H) | Jan 27, 1997 | Substantially Equivalent |
| K965063 | AUDIOTONE (A-552) | Jan 27, 1997 | Substantially Equivalent |
| K965049 | DAHLBERG (A-554) | Jan 27, 1997 | Substantially Equivalent |
| K964669 | MIRACLE-EAR OR AUDIOTONE | Dec 26, 1996 | Substantially Equivalent |
| K964794 | DAHLBERG K-AMP BTE | Dec 23, 1996 | Substantially Equivalent |