BDS-3 Beam Data Scanner
FDA 510(k) K844620 · Varian Assoc., Inc.
510(k) numberK844620
Submission
- Device name
- BDS-3 Beam Data Scanner
- Applicant
- Varian Assoc., Inc.
Palo Alto, CA, US - Received
- November 27, 1984
- Decision date
- July 1, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was BDS-3 Beam Data Scanner cleared by the FDA?
BDS-3 Beam Data Scanner (K844620) received a 510(k) decision of Substantially Equivalent on July 1, 1985, 216 days after the submission was received.
What is the product code of K844620?
The FDA product code is LHO – Instrument, Quality-Assurance, Radiologic, a Class I (low risk) device regulated under 21 CFR 892.1940.