The following data is part of a premarket notification filed by Zewa, Inc. with the FDA for Zewa Mfm-007 Blood Pressure Monitor.
| Device ID | K041491 |
| 510k Number | K041491 |
| Device Name: | ZEWA MFM-007 BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ZEWA, INC. 3537 N.W. 115TH AVENUE Miami, FL 33178 |
| Contact | Thomas Zeindler |
| Correspondent | Thomas Zeindler ZEWA, INC. 3537 N.W. 115TH AVENUE Miami, FL 33178 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-04 |
| Decision Date | 2004-09-20 |
| Summary: | summary |