The following data is part of a premarket notification filed by Sentra Medical Devices, Llc with the FDA for Truepulse Disposable Invasive Blood Pressure Monitoring Kit.
| Device ID | K062342 |
| 510k Number | K062342 |
| Device Name: | TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | SENTRA MEDICAL DEVICES, LLC 2831 WOODMONT DRIVE W Canton, MI 48188 |
| Contact | Karthik Marayan |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-08-11 |
| Decision Date | 2006-09-25 |
| Summary: | summary |