The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Ambulatory Blood Pressure Monitor Spacelabs #90202.
| Device ID | K855127 |
| 510k Number | K855127 |
| Device Name: | AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Hans, P.e. |
| Correspondent | Hans, P.e. SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-08-14 |