Model VPW2877F8, Mammo 5 Power Supply
FDA 510(k) K942778 · Varian Assoc., Inc.
510(k) numberK942778
Submission
- Device name
- Model VPW2877F8, Mammo 5 Power Supply
- Applicant
- Varian Assoc., Inc.
Georgetown, CA - Received
- June 13, 1994
- Decision date
- July 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Model VPW2877F8, Mammo 5 Power Supply cleared by the FDA?
Model VPW2877F8, Mammo 5 Power Supply (K942778) received a 510(k) decision of Substantially Equivalent on July 29, 1994, 46 days after the submission was received.
What is the product code of K942778?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.