Prone Breast Positioning Board, Model #37-018
FDA 510(k) K971382 · Victoreen, Inc.
510(k) numberK971382
Submission
- Device name
- Prone Breast Positioning Board, Model #37-018
- Applicant
- Victoreen, Inc.
Solon, OH, US - Received
- March 14, 1997
- Decision date
- June 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Prone Breast Positioning Board, Model #37-018 cleared by the FDA?
Prone Breast Positioning Board, Model #37-018 (K971382) received a 510(k) decision of Substantially Equivalent on June 6, 1997, 84 days after the submission was received.
What is the product code of K971382?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.