GE Oec Altitude
FDA 510(k) K052039 · Ge Oec Medical Systems
510(k) numberK052039
Submission
- Device name
- GE Oec Altitude
- Applicant
- Ge Oec Medical Systems
Salt Lake City, UT, US - Received
- July 28, 2005
- Decision date
- August 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| K172550 | OEC EliteOXO · Traditional | 11/16/2017SE |
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| K132027 | Oec 9800 PlusOWB · Special | 05/01/2014SE |
| K111551 | Oec(R) 9800, Oec(R) 9800 PlusOWB · Traditional | 10/04/2011SE |
| K073543 | Oec 9900 EliteOWB · Traditional | 05/02/2008SE |
| K061953 | 9900 Plus Mobile Fluoroscopy System with 3D and Navigation OptionsOWB · Traditional | 08/15/2006SE |
| K051490 | GE Oec Everview 7500OXO · Traditional | 07/07/2005SE |
Questions and answers
When was GE Oec Altitude cleared by the FDA?
GE Oec Altitude (K052039) received a 510(k) decision of Substantially Equivalent on August 11, 2005, 14 days after the submission was received.
What is the product code of K052039?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.