FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIONET HEARING AID HI-07
K Number: K853637
·
Decision Sep 23, 1985
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
51
Review Days
24
Basic Information
- Device Name
- RIONET HEARING AID HI-07
- K Number
- K853637
- 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
- August 30, 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 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 |
| 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 |
| K844000 | RIONET HEARING AID HB-73 | Nov 9, 1984 | Substantially Equivalent |