D.I.V.A.S.
FDA 510(k) K812238 · Cgr Medical Corp.
510(k) numberK812238
Submission
- Device name
- D.I.V.A.S.
- Applicant
- Cgr Medical Corp.
Mchenry, IL, US - Received
- August 11, 1981
- Decision date
- September 11, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K833223 | Sonel 3000AIYO · Traditional | 05/09/1984SE |
| K834306 | Phasix-High Frequency GeneratorITY · Traditional | 12/29/1983SE |
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| K833846 | Process 100 STIZO · Traditional | 12/16/1983SE |
| K837465 | Alcyon Rotational Cobalt Therapy · Traditional | 06/28/1983SE |
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Questions and answers
When was D.I.V.A.S. cleared by the FDA?
D.I.V.A.S. (K812238) received a 510(k) decision of Substantially Equivalent on September 11, 1981, 31 days after the submission was received.
What is the product code of K812238?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.