FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPER SPEED POTTER-BUCKY (ESO5-110 & 220)
K Number: K893690
·
Decision Jul 20, 1989
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
26
Applicant Total
2
Review Days
65
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Basic Information
- Device Name
- SUPER SPEED POTTER-BUCKY (ESO5-110 & 220)
- K Number
- K893690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Hofmann X-Ray of America, Inc.
- Date Received
- May 16, 1989
- Decision Date
- July 20, 1989
- 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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Other Clearances by Hofmann X-Ray of America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K851011 | HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR | Apr 10, 1985 | Substantially Equivalent |