CardioConfirm
FDA 510(k) K161465 · Mortara Instrument, Inc.
510(k) numberK161465
Submission
- Device name
- CardioConfirm
- Applicant
- Mortara Instrument, Inc.
Milwaukee, WI, US - Received
- May 27, 2016
- Decision date
- September 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 CardioConfirm cleared by the FDA?
CardioConfirm (K161465) received a 510(k) decision of Substantially Equivalent on September 3, 2016, 99 days after the submission was received.
What is the product code of K161465?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.