FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARALUEN HEAD SHIELD
K Number: K810868
·
Decision May 13, 1981
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
38
Applicant Total
3
Review Days
43
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Basic Information
- Device Name
- ARALUEN HEAD SHIELD
- K Number
- K810868
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6900
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Araluen, Inc.
- Date Received
- March 31, 1981
- Decision Date
- May 13, 1981
- Product Code
- FPP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPP | Stretcher, Hand-Carried | FDA class 1 | General Hospital |
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