Patientnet Monitoring System

FDA 510(k) K020524 · General Electric Medical Systems Information Techn

Substantially Equivalent

510(k) numberK020524

Submission

Device name
Patientnet Monitoring System
Applicant
General Electric Medical Systems Information Techn
Tustin, CA, US
Received
February 19, 2002
Decision date
March 20, 2002
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MSX – System, Network And Communication, Physiological Monitors
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2300
Specialty
Cardiovascular
Life-sustaining
Yes

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Questions and answers

When was Patientnet Monitoring System cleared by the FDA?

Patientnet Monitoring System (K020524) received a 510(k) decision of Substantially Equivalent on March 20, 2002, 29 days after the submission was received.

What is the product code of K020524?

The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.