Medgraphics Ultima System
FDA 510(k) K061731 · Medical Graphics Corp.
510(k) numberK061731
Submission
- Device name
- Medgraphics Ultima System
- Applicant
- Medical Graphics Corp.
St. Paul, MN, US - Received
- June 20, 2006
- Decision date
- September 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZL – Computer, Oxygen-Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1730
- Specialty
- Anesthesiology
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Questions and answers
When was Medgraphics Ultima System cleared by the FDA?
Medgraphics Ultima System (K061731) received a 510(k) decision of Substantially Equivalent on September 6, 2006, 78 days after the submission was received.
What is the product code of K061731?
The FDA product code is BZL – Computer, Oxygen-Uptake, a Class II (moderate risk) device regulated under 21 CFR 868.1730.