The following data is part of a premarket notification filed by Oxford Medilog, Inc. with the FDA for Python Ambulatory Blood Pressure Monitoring System.
Device ID | K874917 |
510k Number | K874917 |
Device Name: | PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
Contact | Michael J Smith |
Correspondent | Michael J Smith OXFORD MEDILOG, INC. 11526 53RD. ST. N. Clearwater, FL 33520 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-03 |
Decision Date | 1988-05-10 |