VJW2919 Pneumatic Compression Upgrade
FDA 510(k) K920938 · Varian Canada, Inc.
510(k) numberK920938
Submission
- Device name
- VJW2919 Pneumatic Compression Upgrade
- Applicant
- Varian Canada, Inc.
Canada L7g 2j4, CA - Received
- February 27, 1992
- Decision date
- June 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was VJW2919 Pneumatic Compression Upgrade cleared by the FDA?
VJW2919 Pneumatic Compression Upgrade (K920938) received a 510(k) decision of Substantially Equivalent on June 17, 1992, 111 days after the submission was received.
What is the product code of K920938?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.