The following data is part of a premarket notification filed by Meditec Co., Ltd. with the FDA for Digital Blood Pressure Monitor, Model Md-550.
| Device ID | K002655 |
| 510k Number | K002655 |
| Device Name: | DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MEDITEC CO., LTD. #206 GADONG, SUNNAM APT FACTO YATAPDONG, BUNGDANGGU Sunnamcity, Kyunggido, KR 463-070 |
| Contact | D H Chang |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-08-25 |
| Decision Date | 2000-09-06 |