The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Smart Dongle Blood Glucose Monitoring System.
| Device ID | K162382 |
| 510k Number | K162382 |
| Device Name: | Smart Dongle Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Contact | Paul Liu |
| Correspondent | Paul Liu TaiDoc Technology Corporation B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Product Code | NBW |
| Subsequent Product Code | JQP |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-24 |
| Decision Date | 2017-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04713106027180 | K162382 | 000 |
| 04713106027173 | K162382 | 000 |
| 04710469871498 | K162382 | 000 |
| 00860003222324 | K162382 | 000 |
| 00860003222317 | K162382 | 000 |
| 00860003222300 | K162382 | 000 |