The following data is part of a premarket notification filed by Microlife Corp. with the FDA for Microlife Upper Arm Manual Blood Pressure Monitor, Model Bp3mr1-h (bp A50).
| Device ID | K073397 |
| 510k Number | K073397 |
| Device Name: | MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-03 |
| Decision Date | 2007-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782074852 | K073397 | 000 |
| 00634782576097 | K073397 | 000 |