The following data is part of a premarket notification filed by Endophys Holdings, Llc with the FDA for Endophys Blood Pressure Monitor.
| Device ID | K160945 |
| 510k Number | K160945 |
| Device Name: | Endophys Blood Pressure Monitor |
| Classification | Computer, Blood-pressure |
| Applicant | ENDOPHYS HOLDINGS, LLC 1601 ELM STREET Dallas, TX 75201 |
| Contact | Rebecca K. Pine |
| Correspondent | Rebecca K. Pine ENDOPHYS HOLDINGS, LLC 1601 ELM STREET Dallas, TX 75201 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-05 |
| Decision Date | 2016-09-26 |
| Summary: | summary |