FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FCW TUBE STAND
K Number: K862827
·
Decision Aug 1, 1986
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
4
Review Days
7
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Basic Information
- Device Name
- FCW TUBE STAND
- K Number
- K862827
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Garrels X-Ray Products, Inc.
- Date Received
- July 25, 1986
- Decision Date
- August 1, 1986
- Product Code
- IYB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | FDA class 1 | Radiology |
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