Acustar I Advanced Surgical Navigation System
FDA 510(k) K944612 · Codman & Shurtleff, Inc.
510(k) numberK944612
Submission
- Device name
- Acustar I Advanced Surgical Navigation System
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- September 19, 1994
- Decision date
- December 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Acustar I Advanced Surgical Navigation System cleared by the FDA?
Acustar I Advanced Surgical Navigation System (K944612) received a 510(k) decision of Substantially Equivalent on December 11, 1995, 448 days after the submission was received.
What is the product code of K944612?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.