The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Sentorr Arterial Pressure Sensor.
Device ID | K880830 |
510k Number | K880830 |
Device Name: | SENTORR ARTERIAL PRESSURE SENSOR |
Classification | Transducer, Pressure, Catheter Tip |
Applicant | OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa, FL 33702 |
Contact | Jill Phillips |
Correspondent | Jill Phillips OHMEDA MEDICAL 2007 PAN AM CIRCLE Tampa, FL 33702 |
Product Code | DXO |
CFR Regulation Number | 870.2870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-01 |
Decision Date | 1988-08-12 |