The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Patientnet Monitoring System.
Device ID | K020524 |
510k Number | K020524 |
Device Name: | PATIENTNET MONITORING SYSTEM |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 15222 DEL AMO AVE. Tustin, CA 92780 |
Contact | Diana M Thorson |
Correspondent | Diana M Thorson GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 15222 DEL AMO AVE. Tustin, CA 92780 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-19 |
Decision Date | 2002-03-20 |
Summary: | summary |