GE Oec Altitude
FDA 510(k) K071717 · Shimadzu Corp.
510(k) numberK071717
Submission
- Device name
- GE Oec Altitude
- Applicant
- Shimadzu Corp.
Kyoto, JP - Received
- June 22, 2007
- Decision date
- July 5, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was GE Oec Altitude cleared by the FDA?
GE Oec Altitude (K071717) received a 510(k) decision of Substantially Equivalent on July 5, 2007, 13 days after the submission was received.
What is the product code of K071717?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.