Centurion Central Station Arrhythmia Patient Monitoring System
FDA 510(k) K980045 · Invivo Research, Inc.
510(k) numberK980045
Submission
- Device name
- Centurion Central Station Arrhythmia Patient Monitoring System
- Applicant
- Invivo Research, Inc.
Orlando, FL, US - Received
- January 6, 1998
- Decision date
- November 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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Questions and answers
When was Centurion Central Station Arrhythmia Patient Monitoring System cleared by the FDA?
Centurion Central Station Arrhythmia Patient Monitoring System (K980045) received a 510(k) decision of Substantially Equivalent on November 16, 1998, 314 days after the submission was received.
What is the product code of K980045?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.