The following data is part of a premarket notification filed by Meditec Co., Ltd. with the FDA for Fuzzy Automatic Blood Pressure Monitor Models Md-750, Md-770, Md-800.
| Device ID | K992328 |
| 510k Number | K992328 |
| Device Name: | FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800 |
| 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 | Carol 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 | 1999-07-12 |
| Decision Date | 1999-07-21 |
| Summary: | summary |