FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HI-LO ELEVATOR FLAT TABLE
K Number: K862825
·
Decision Sep 4, 1986
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
26
Applicant Total
4
Review Days
41
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Basic Information
- Device Name
- HI-LO ELEVATOR FLAT TABLE
- K Number
- K862825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Garrels X-Ray Products, Inc.
- Date Received
- July 25, 1986
- Decision Date
- September 4, 1986
- Product Code
- IXQ
- 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 |
|---|---|---|---|
| IXQ | Table, Radiographic, Stationary Top | FDA class 2 | Radiology |
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