FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADJUSTABLE ARM SUPPORT
K Number: K770065
·
Decision Feb 2, 1977
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
0
Applicant Total
3
Review Days
21
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
- ADJUSTABLE ARM SUPPORT
- K Number
- K770065
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Richard F. Kronner, M.D.
- Date Received
- January 12, 1977
- Decision Date
- February 2, 1977
- Product Code
- IOY
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IOY | Support, Arm | FDA class 1 | Physical Medicine |