The following data is part of a premarket notification filed by Meditech Kft. with the FDA for Meditech Ambulatory Blood Pressure Monitor, Model Abpm-05.
| Device ID | K071960 |
| 510k Number | K071960 |
| Device Name: | MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MEDITECH KFT. INDUSTRIAL PARK 13 M.P. MISGAV Mizpe Aviv, IL 20187 |
| Contact | Benny Arazy |
| Correspondent | Benny Arazy MEDITECH KFT. INDUSTRIAL PARK 13 M.P. MISGAV Mizpe Aviv, IL 20187 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-16 |
| Decision Date | 2007-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05999056500051 | K071960 | 000 |