The following data is part of a premarket notification filed by Bionet Co., Ltd. with the FDA for Bionet Bm3plus Patient Monitor.
| Device ID | K082008 |
| 510k Number | K082008 |
| Device Name: | BIONET BM3PLUS PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | BIONET CO., LTD. 2600 MISSION ST., SUITE 100 San Marino, CA 91108 |
| Contact | Yingchao Xiao |
| Correspondent | Yingchao Xiao BIONET CO., LTD. 2600 MISSION ST., SUITE 100 San Marino, CA 91108 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-15 |
| Decision Date | 2008-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809276940643 | K082008 | 000 |