The following data is part of a premarket notification filed by Meditech Kft. with the FDA for Meditech Model Abpm-04.
| Device ID | K051149 |
| 510k Number | K051149 |
| Device Name: | MEDITECH MODEL ABPM-04 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MEDITECH KFT. INDUSTRIAL PARK 13 MIZPE AVIV M.p. Misgav, IL 20187 |
| Contact | Benny Arazy |
| Correspondent | Benny Arazy MEDITECH KFT. INDUSTRIAL PARK 13 MIZPE AVIV M.p. Misgav, IL 20187 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-04 |
| Decision Date | 2005-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05999056500044 | K051149 | 000 |