Trauma View Rad Syst Model #B-Trv/Stret Mobil Tabl
FDA 510(k) K912696 · Bennett X-Ray Corp.
510(k) numberK912696
Submission
- Device name
- Trauma View Rad Syst Model #B-Trv/Stret Mobil Tabl
- Applicant
- Bennett X-Ray Corp.
Copiague, NY, US - Received
- June 18, 1991
- Decision date
- September 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Trauma View Rad Syst Model #B-Trv/Stret Mobil Tabl cleared by the FDA?
Trauma View Rad Syst Model #B-Trv/Stret Mobil Tabl (K912696) received a 510(k) decision of Substantially Equivalent on September 16, 1991, 90 days after the submission was received.
What is the product code of K912696?
The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.