FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
GE OEC ALTITUDE
K Number: K071717
·
Decision Jul 5, 2007
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
195
Applicant Total
49
Review Days
13
Basic Information
- Device Name
- GE OEC ALTITUDE
- K Number
- K071717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SHIMADZU CORP.
- Date Received
- June 22, 2007
- Decision Date
- July 5, 2007
- Product Code
- IZI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
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| K072006 | DAR-9400F | Aug 31, 2007 | Substantially Equivalent |
| K062360 | BRANSIST SAFIRE | Oct 5, 2006 | Substantially Equivalent |
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