The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Automatic Blood Pressure Monitor, Model Bp3ac1-1pc.
| Device ID | K060686 |
| 510k Number | K060686 |
| Device Name: | MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MICROLIFE INTELLECTUAL PROPERTY GMBH MAX SCHMIDHEINY-STRASSE 201 Heerbrugg, CH 9435 |
| Contact | Ariel Wang |
| Correspondent | Tzu-wei Li CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL BLDG. 16, 321 KUANG FU RD,SEC2 Hsinchu,, TW |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-03-15 |
| Decision Date | 2006-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782576127 | K060686 | 000 |