The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Patient Monitor.
Device ID | K110922 |
510k Number | K110922 |
Device Name: | PATIENT MONITOR |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD1019 Shenzhen, Guangdong, CN 518067 |
Contact | Randy Jiang |
Correspondent | Randy Jiang EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD1019 Shenzhen, Guangdong, CN 518067 |
Product Code | MHX |
Subsequent Product Code | CBQ |
Subsequent Product Code | CBR |
Subsequent Product Code | CBS |
Subsequent Product Code | CCK |
Subsequent Product Code | CCL |
Subsequent Product Code | DQA |
Subsequent Product Code | DRT |
Subsequent Product Code | DSA |
Subsequent Product Code | DSF |
Subsequent Product Code | DSK |
Subsequent Product Code | DXN |
Subsequent Product Code | FLL |
Subsequent Product Code | MLD |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-01 |
Decision Date | 2011-07-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06944413807334 | K110922 | 000 |
06944413800823 | K110922 | 000 |
06944413800816 | K110922 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PATIENT MONITOR 74564296 1942340 Live/Registered |
Brown, Frank L. 1994-08-22 |