FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CRAIGWELL MASTER HEARING AID MHA
K Number: K854126
·
Decision Jan 16, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
3
Review Days
99
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Basic Information
- Device Name
- CRAIGWELL MASTER HEARING AID MHA
- K Number
- K854126
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3330
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Craigwell Electronics, Ltd.
- Date Received
- October 9, 1985
- Decision Date
- January 16, 1986
- Product Code
- KHL
- 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 |
|---|---|---|---|
| KHL | Hearing Aid, Master | FDA class 2 | Ear, Nose, Throat |
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