Mortara Monitoring Waveform Viewer
FDA 510(k) K141811 · Mortara Instrument, Inc.
510(k) numberK141811
Submission
- Device name
- Mortara Monitoring Waveform Viewer
- Applicant
- Mortara Instrument, Inc.
Milwaukee, WI, US - Received
- July 7, 2014
- Decision date
- November 19, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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Questions and answers
When was Mortara Monitoring Waveform Viewer cleared by the FDA?
Mortara Monitoring Waveform Viewer (K141811) received a 510(k) decision of Substantially Equivalent on November 19, 2014, 135 days after the submission was received.
What is the product code of K141811?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.