FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RION DIAGNOSTIC AUDIOMETER
K Number: K802207
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
51
Review Days
15
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Basic Information
- Device Name
- RION DIAGNOSTIC AUDIOMETER
- K Number
- K802207
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Rion Acoustic Instruments, Inc.
- Date Received
- September 11, 1980
- Decision Date
- September 26, 1980
- Product Code
- EWO
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | 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 |
| 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 |