The following data is part of a premarket notification filed by Asia Pacific Microsystems, Inc. with the FDA for Apm Blood Pressure Monitor, Model Bp108a.
Device ID | K040159 |
510k Number | K040159 |
Device Name: | APM BLOOD PRESSURE MONITOR, MODEL BP108A |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | ASIA PACIFIC MICROSYSTEMS, INC. NO. 58, FU-CHIUN ST. Hsin Chu City, TW 300 |
Contact | Ke-min Jen |
Correspondent | Ke-min Jen ASIA PACIFIC MICROSYSTEMS, INC. NO. 58, FU-CHIUN ST. Hsin Chu City, TW 300 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-01-23 |
Decision Date | 2004-03-22 |
Summary: | summary |