Veridose V (Five), Model Number 37-705
FDA 510(k) K964952 · Victoreen, Inc.
510(k) numberK964952
Submission
- Device name
- Veridose V (Five), Model Number 37-705
- Applicant
- Victoreen, Inc.
Cleveland, OH, US - Received
- December 10, 1996
- Decision date
- July 21, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K940660 | Model 37-720 Dual Diode Dosimetry SystemIYE · Traditional | 12/09/1994SE |
| K935435 | Nuclear Assoc 37-08 Ser, Raycast HP Radio Immob SystIYE · Traditional | 07/29/1994SE |
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Questions and answers
When was Veridose V (Five), Model Number 37-705 cleared by the FDA?
Veridose V (Five), Model Number 37-705 (K964952) received a 510(k) decision of Substantially Equivalent on July 21, 1997, 223 days after the submission was received.
What is the product code of K964952?
The FDA product code is JAD – System, Therapeutic, X-Ray, a Class II (moderate risk) device regulated under 21 CFR 892.5900.