Nomos Motorized Crane II
FDA 510(k) K013036 · Nomos Corp.
510(k) numberK013036
Submission
- Device name
- Nomos Motorized Crane II
- Applicant
- Nomos Corp.
Sewickley, PA, US - Received
- September 10, 2001
- Decision date
- December 7, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Nomos Motorized Crane II cleared by the FDA?
Nomos Motorized Crane II (K013036) received a 510(k) decision of Substantially Equivalent on December 7, 2001, 88 days after the submission was received.
What is the product code of K013036?
The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.