The following data is part of a premarket notification filed by Panasonic Corporation (panasonic) with the FDA for Panasonic Wrist Blood Pressure Meter, Model Ew284.
| Device ID | K981542 |
| 510k Number | K981542 |
| Device Name: | PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | PANASONIC CORPORATION (PANASONIC) 1730 PENNSYLVANIA AVENUE N.W. Washington, DC 20006 |
| Contact | Edward M Basile |
| Correspondent | Edward M Basile PANASONIC CORPORATION (PANASONIC) 1730 PENNSYLVANIA AVENUE N.W. Washington, DC 20006 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-29 |
| Decision Date | 1999-03-03 |
| Summary: | summary |