BIOMONITOR
Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
BIOTRONIK, INC.
The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Biomonitor.
Pre-market Notification Details
| Device ID | K132960 |
| 510k Number | K132960 |
| Device Name: | BIOMONITOR |
| Classification | Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | MXD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-20 |
| Decision Date | 2014-06-06 |
| Summary: | summary |
Trademark Results [BIOMONITOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOMONITOR 86538311 5046341 Live/Registered |
BIOTRONIK SE & Co. KG 2015-02-18 |
 BIOMONITOR 79053841 3746900 Dead/Cancelled |
BIOTRONIK SE & Co. KG 2008-01-30 |
 BIOMONITOR 79047745 3647657 Dead/Cancelled |
BIOTRONIK SE & Co. KG 2007-11-01 |
 BIOMONITOR 78214992 2940748 Dead/Cancelled |
Applera Corporation 2003-02-14 |
 BIOMONITOR 73014956 1016744 Dead/Expired |
BIOCONTROL COMPANY 1974-03-04 |
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