FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEDI-SPIDER STRAP
K Number: K061721
·
Decision Aug 17, 2006
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
0
Applicant Total
1
Review Days
59
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Basic Information
- Device Name
- PEDI-SPIDER STRAP
- K Number
- K061721
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6900
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Emergency Products and Research
- Date Received
- June 19, 2006
- Decision Date
- August 17, 2006
- Product Code
- NZD
- 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 |
|---|---|---|---|
| NZD | Stretcher, Patient Restraint | FDA class 1 | General Hospital |