FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OVERLOAD WARNING DEVICE
K Number: K770405
·
Decision Mar 10, 1977
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
10
Applicant Total
402
Review Days
7
Basic Information
- Device Name
- OVERLOAD WARNING DEVICE
- K Number
- K770405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5575
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- SYNTHES (USA)
- Date Received
- March 3, 1977
- Decision Date
- March 10, 1977
- Product Code
- IRN
- 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 |
|---|---|---|---|
| IRN | Device, Warning, Overload, External Limb, Powered | FDA class 2 | Physical Medicine |
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