FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE HENLEY BOARD S.I.D. SPINAL IMMOBILIZATION DEVI
K Number: K852100
·
Decision Jul 24, 1985
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
1
Review Days
70
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Basic Information
- Device Name
- THE HENLEY BOARD S.I.D. SPINAL IMMOBILIZATION DEVI
- K Number
- K852100
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Henley Board, Inc.
- Date Received
- May 15, 1985
- Decision Date
- July 24, 1985
- Product Code
- FPD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
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