The following data is part of a premarket notification filed by Mediana Co., Ltd. with the FDA for Patient Monitor.
Device ID | K112190 |
510k Number | K112190 |
Device Name: | PATIENT MONITOR |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | MEDIANA CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
Contact | Charlie Mack |
Correspondent | Charlie Mack MEDIANA CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-29 |
Decision Date | 2011-11-09 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PATIENT MONITOR 74564296 1942340 Live/Registered |
Brown, Frank L. 1994-08-22 |