Quantien Measurement System
FDA 510(k) K123984 · Radi Medical Systems AB
510(k) numberK123984
Submission
- Device name
- Quantien Measurement System
- Applicant
- Radi Medical Systems AB
Uppsala, SE - Received
- December 26, 2012
- Decision date
- March 28, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was Quantien Measurement System cleared by the FDA?
Quantien Measurement System (K123984) received a 510(k) decision of Substantially Equivalent on March 28, 2013, 92 days after the submission was received.
What is the product code of K123984?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.