The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for 2120 Non-invasive Blood Pressure Monitor W/cuff.
Device ID | K861987 |
510k Number | K861987 |
Device Name: | 2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | OHMEDA MEDICAL 355 INVERNESS DR.SOUTH Englewood, CO 80112 -5810 |
Contact | Deana Dickerson |
Correspondent | Deana Dickerson OHMEDA MEDICAL 355 INVERNESS DR.SOUTH Englewood, CO 80112 -5810 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-22 |
Decision Date | 1987-02-03 |