Instrumentarium Ulf MR Imaging System Version 110
FDA 510(k) K883650 · Instrumentarium Corp.
510(k) numberK883650
Submission
- Device name
- Instrumentarium Ulf MR Imaging System Version 110
- Applicant
- Instrumentarium Corp.
Arlington, VA, US - Received
- August 29, 1988
- Decision date
- September 16, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Instrumentarium Ulf MR Imaging System Version 110 cleared by the FDA?
Instrumentarium Ulf MR Imaging System Version 110 (K883650) received a 510(k) decision of Substantially Equivalent on September 16, 1988, 18 days after the submission was received.
What is the product code of K883650?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.