The following data is part of a premarket notification filed by Endophys, Inc. with the FDA for Endophys Blood Pressure Monitor.
| Device ID | K141615 |
| 510k Number | K141615 |
| Device Name: | ENDOPHYS BLOOD PRESSURE MONITOR |
| Classification | Computer, Blood-pressure |
| Applicant | ENDOPHYS, INC. 755 N. MATHILDA, AVE. SUITE 100 Sunnyvale, CA 94085 |
| Contact | Ronald S Warren |
| Correspondent | Ronald S Warren ENDOPHYS, INC. 755 N. MATHILDA, AVE. SUITE 100 Sunnyvale, CA 94085 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-16 |
| Decision Date | 2015-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852004007000 | K141615 | 000 |