The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Ambulatory Blood Pressure (abp) 92506 Report Management System (rms), Model 92506.
| Device ID | K031479 |
| 510k Number | K031479 |
| Device Name: | AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | DATEX-OHMEDA, INC. 5150 220TH AVE SE Issaquah, WA 98029 |
| Contact | Al Van Houdt |
| Correspondent | Al Van Houdt DATEX-OHMEDA, INC. 5150 220TH AVE SE Issaquah, WA 98029 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-08 |
| Decision Date | 2003-06-06 |
| Summary: | summary |