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 |