Vision VXC Central Station, Model 4300
FDA 510(k) K061675 · Invivo Corporation
510(k) numberK061675
Submission
- Device name
- Vision VXC Central Station, Model 4300
- Applicant
- Invivo Corporation
Orlando, FL, US - Received
- June 14, 2006
- Decision date
- August 2, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Vision VXC Central Station, Model 4300 cleared by the FDA?
Vision VXC Central Station, Model 4300 (K061675) received a 510(k) decision of Substantially Equivalent on August 2, 2006, 49 days after the submission was received.
What is the product code of K061675?
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.