The following data is part of a premarket notification filed by Microlife Corp. with the FDA for Microlife Upper Arm Automatic Blood Pressure Monitor, Model Bp-3bto-1, With Optional Thermal Printer, Model Pr 1ka1.
| Device ID | K013485 |
| 510k Number | K013485 |
| Device Name: | MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1 |
| 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 | 2001-10-19 |
| Decision Date | 2002-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04045396211889 | K013485 | 000 |
| 04045396211872 | K013485 | 000 |
| 04045396155374 | K013485 | 000 |