FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRIME ZOOM STRETCHER
K Number: K140095
·
Decision May 20, 2014
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
11
Applicant Total
81
Review Days
126
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Basic Information
- Device Name
- PRIME ZOOM STRETCHER
- K Number
- K140095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3690
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corporation
- Date Received
- January 14, 2014
- Decision Date
- May 20, 2014
- Product Code
- INK
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| INK | Stretcher, Wheeled, Powered | FDA class 2 | Physical Medicine |
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