FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIONET HEARING AID HB-71P
K Number: K852452
·
Decision Aug 21, 1985
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
51
Review Days
72
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RIONET HEARING AID HB-71P
- K Number
- K852452
- 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 10, 1985
- Decision Date
- August 21, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESD), ordered by most recent decision date.
Lyric4 Hearing Aid
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC2
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
INSOUND XT SERIES HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
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 |
| K853637 | RIONET HEARING AID HI-07 | Sep 23, 1985 | 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 |
| 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 |