The following data is part of a premarket notification filed by Microlife Corp. with the FDA for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Bp3mq1-2d.
Device ID | K080337 |
510k Number | K080337 |
Device Name: | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Contact | Susan D Goldstein-falk |
Correspondent | Susan D Goldstein-falk MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-02-08 |
Decision Date | 2008-05-13 |
Summary: | summary |