FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANQUIL TRI-BTE
K Number: K061459
·
Decision Jun 30, 2006
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
76
Applicant Total
5
Review Days
35
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Basic Information
- Device Name
- TRANQUIL TRI-BTE
- K Number
- K061459
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.3400
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- General Hearing Instruments, Inc.
- Date Received
- May 26, 2006
- Decision Date
- June 30, 2006
- Product Code
- KLW
- 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 |
|---|---|---|---|
| KLW | Masker, Tinnitus | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by General Hearing Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | Mar 6, 1998 | Substantially Equivalent |
| K971399 | AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC | Jun 13, 1997 | Substantially Equivalent |
| K943144 | AURIS CIC | Jul 20, 1994 | Substantially Equivalent |
| K850123 | IN-TH-EAR HEARING AID | Mar 21, 1985 | Substantially Equivalent |