CTF Model 9300
FDA 510(k) K813588 · Thomson-Csf Broadcast, Inc.
510(k) numberK813588
Submission
- Device name
- CTF Model 9300
- Applicant
- Thomson-Csf Broadcast, Inc.
Mchenry, IL, US - Received
- December 28, 1981
- Decision date
- February 4, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K222240 | Explorer Air® IIIZI · Traditional | Surgvision GmbH | 02/28/2023SE |
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Questions and answers
When was CTF Model 9300 cleared by the FDA?
CTF Model 9300 (K813588) received a 510(k) decision of Substantially Equivalent on February 4, 1982, 38 days after the submission was received.
What is the product code of K813588?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.