The following data is part of a premarket notification filed by Vsm Medtech Ltd. with the FDA for Bptru Vital Signs Monitor, Model Bpm-300, & Bptru Portable Automated Non-invasive Blood Pressure And Temperature Monitor.
| Device ID | K023078 |
| 510k Number | K023078 |
| Device Name: | BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | VSM MEDTECH LTD. 675 WEST HASTINGS ST., 15TH FL Vancouver, B.c., CA V6b 1n2 |
| Contact | Daryl Wisdahl |
| Correspondent | Daryl Wisdahl VSM MEDTECH LTD. 675 WEST HASTINGS ST., 15TH FL Vancouver, B.c., CA V6b 1n2 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-16 |
| Decision Date | 2003-03-21 |
| Summary: | summary |