The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Glucomanager Data Management Software.
| Device ID | K091229 |
| 510k Number | K091229 |
| Device Name: | GLUCOMANAGER DATA MANAGEMENT SOFTWARE |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | EPS BIO TECHNOLOGY CORP. 2 F,NO.49-2, LANE 2, SEC. 2, GUANG FU ROAD Hsinchu City, TW 300 |
| Contact | Y.c. Lei |
| Correspondent | Y.c. Lei EPS BIO TECHNOLOGY CORP. 2 F,NO.49-2, LANE 2, SEC. 2, GUANG FU ROAD Hsinchu City, TW 300 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-27 |
| Decision Date | 2009-07-31 |
| Summary: | summary |