Ivr Master
FDA 510(k) K945389 · Shimadzu Corp.
510(k) numberK945389
Submission
- Device name
- Ivr Master
- Applicant
- Shimadzu Corp.
Torrance, CA, US - Received
- November 3, 1994
- Decision date
- February 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K142341 | X-Ray TV System Sonialvision G4JAA · Abbreviated | 03/06/2015SE |
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Questions and answers
When was Ivr Master cleared by the FDA?
Ivr Master (K945389) received a 510(k) decision of Substantially Equivalent on February 7, 1995, 96 days after the submission was received.
What is the product code of K945389?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.