The following data is part of a premarket notification filed by Meditec Co., Ltd. with the FDA for Noninvasive Blood Pressure Monitor, Models Md-880b And Md-900t.
| Device ID | K041789 |
| 510k Number | K041789 |
| Device Name: | NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MEDITEC CO., LTD. 1733 CANTON LANE Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Chan Yo Won UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-07-02 |
| Decision Date | 2004-07-15 |
| Summary: | summary |