The following data is part of a premarket notification filed by Broadmaster Biotech Corporation with the FDA for Broadmaster Healthcare System.
| Device ID | K130621 |
| 510k Number | K130621 |
| Device Name: | BROADMASTER HEALTHCARE SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BROADMASTER BIOTECH CORPORATION 7F, NO. 168-2, LIANCHENG Zhonghe City, TW 23553 |
| Contact | Roger Lai |
| Correspondent | Roger Lai BROADMASTER BIOTECH CORPORATION 7F, NO. 168-2, LIANCHENG Zhonghe City, TW 23553 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-08 |
| Decision Date | 2013-07-30 |
| Summary: | summary |