FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIONET HEARING AID HB 69 T
K Number: K811530
·
Decision Jun 26, 1981
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
51
Review Days
25
Basic Information
- Device Name
- RIONET HEARING AID HB 69 T
- K Number
- K811530
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- RION ACOUSTIC INSTRUMENTS, INC.
- Date Received
- June 1, 1981
- Decision Date
- June 26, 1981
- 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 RION ACOUSTIC INSTRUMENTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K874510 | RIONET HEARING AID HB-75 | Feb 23, 1988 | Substantially Equivalent |
| K862670 | RIONET HEARING AID HB-35PT | Jul 31, 1986 | Substantially Equivalent |
| K861728 | RIONET HEARING AID | May 27, 1986 | Substantially Equivalent |
| K853636 | RIONET HEARING AID HI-06 | Sep 23, 1985 | Substantially Equivalent |
| K853638 | RIONET HEARING AID | Sep 23, 1985 | Substantially Equivalent |
| K853637 | RIONET HEARING AID HI-07 | Sep 23, 1985 | Substantially Equivalent |
| K852453 | RIONET HEARING AID HB-69HT | Aug 22, 1985 | Substantially Equivalent |
| K852452 | RIONET HEARING AID HB-71P | Aug 21, 1985 | Substantially Equivalent |
| K852451 | RIONET HEARING AID HB-34HT | Aug 21, 1985 | Substantially Equivalent |
| K844059 | RIONET HEARING AID HB-34AS | Dec 3, 1984 | Substantially Equivalent |