Vacudap, Model 2000, 2001
FDA 510(k) K974112 · Victoreen, Inc.
510(k) numberK974112
Submission
- Device name
- Vacudap, Model 2000, 2001
- Applicant
- Victoreen, Inc.
Solon, OH, US - Received
- October 31, 1997
- Decision date
- January 29, 1998
- 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 Vacudap, Model 2000, 2001 cleared by the FDA?
Vacudap, Model 2000, 2001 (K974112) received a 510(k) decision of Substantially Equivalent on January 29, 1998, 90 days after the submission was received.
What is the product code of K974112?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.