Brand Name | ZM-541PA |
Type of Device | TELEMETRY TRANSMITTER |
Manufacturer (Section D) |
|
Manufacturer Contact |
|
1-31-4 nishiochia |
shinjuku-ku, tokyo 161-8-560
|
7050350
|
|
MDR Report Key | 4197398 |
MDR Text Key | 5040770 |
Report Number | 8030229-2014-00056 |
Device Sequence Number | 1 |
Product Code |
DRT
|
Combination Product (y/n) | N |
PMA/PMN Number | K043517 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Type of Report
| Initial |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Initial Date Manufacturer Received |
09/10/2014
|
Initial Date FDA Received | 09/26/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/01/2011 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|