Stenoscop
FDA 510(k) K843235 · Cgr Medical Corp.
510(k) numberK843235
Submission
- Device name
- Stenoscop
- Applicant
- Cgr Medical Corp.
Columbia, MD, US - Received
- August 16, 1984
- Decision date
- November 8, 1984
- 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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| K837465 | Alcyon Rotational Cobalt Therapy · Traditional | 06/28/1983SE |
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Questions and answers
When was Stenoscop cleared by the FDA?
Stenoscop (K843235) received a 510(k) decision of Substantially Equivalent on November 8, 1984, 84 days after the submission was received.
What is the product code of K843235?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.