The following data is part of a premarket notification filed by Meditech Ltd. with the FDA for Meditech Abpm-06 (bp6).
| Device ID | K201332 |
| 510k Number | K201332 |
| Device Name: | Meditech ABPM-06 (BP6) |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Meditech Ltd. 24 Mikszath Kalman Utca Budapest, HU 1184 |
| Contact | Gabor Kazi |
| Correspondent | Ray Kelly Arazy Group Consultants Inc. 3422 Leonardo Lane New Smyrna Beach, FL 32168 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-19 |
| Decision Date | 2021-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05999056500068 | K201332 | 000 |