FDA 510(k)
Substantially Equivalent
🇺🇸 United States
RIONET HEARING AID
K Number: K821508
·
Decision Jun 9, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
51
Review Days
19
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Basic Information
- Device Name
- RIONET HEARING AID
- K Number
- K821508
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Rion Acoustic Instruments, Inc.
- Date Received
- May 21, 1982
- Decision Date
- June 9, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- Third Party
- N
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 |
| 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 |