FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
RION ELECTRO-PALATOGRAPH MODEL DP-01
K Number: K802870
·
Decision Dec 17, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
4
Review Days
33
Basic Information
- Device Name
- RION ELECTRO-PALATOGRAPH MODEL DP-01
- K Number
- K802870
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Kindel & Anderson
- Date Received
- November 14, 1980
- Decision Date
- December 17, 1980
- Product Code
- LEZ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LEZ | Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact) | FDA unclassified | Unknown |
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