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, Cardio+ (bp4gapo-2m).
| Device ID | K122013 |
| 510k Number | K122013 |
| Device Name: | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) |
| 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 | 2012-07-10 |
| Decision Date | 2013-05-13 |
| Summary: | summary |