The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Advanced Gd40 And Fora Advanced Gd40 Pro Blood Glucose And ß-ketone Monitoring Systems.
| Device ID | K161738 |
| 510k Number | K161738 |
| Device Name: | FORA ADVANCED GD40 And FORA ADVANCED GD40 Pro Blood Glucose And ß-Ketone Monitoring Systems |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TAIDOC TECHNOLOGY CORPORATION 6F, NO.127, WUGONG 2ND RD., WUGU DISTRICT New Taipei City, TW 24888 |
| Contact | Paul Liu |
| Correspondent | Paul Liu TAIDOC TECHNOLOGY CORPORATION 6F, NO.127, WUGONG 2ND RD., WUGU DISTRICT New Taipei City, TW 24888 |
| Product Code | NBW |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-23 |
| Decision Date | 2016-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10370393216102 | K161738 | 000 |
| 00858538007004 | K161738 | 000 |
| 00851225008032 | K161738 | 000 |
| 00851225008025 | K161738 | 000 |
| 00851225008001 | K161738 | 000 |
| 00816042013331 | K161738 | 000 |
| 00816042013850 | K161738 | 000 |
| 00850001462334 | K161738 | 000 |
| 00816042013164 | K161738 | 000 |
| 00850001462419 | K161738 | 000 |
| 80816042013665 | K161738 | 000 |
| 00816042013874 | K161738 | 000 |
| 00860005745920 | K161738 | 000 |
| 00860005745906 | K161738 | 000 |
| 80816042013573 | K161738 | 000 |
| 00858538007103 | K161738 | 000 |
| 00858538007202 | K161738 | 000 |
| 10370393215204 | K161738 | 000 |
| 10370393001081 | K161738 | 000 |
| 00816042013171 | K161738 | 000 |
| 00816042013157 | K161738 | 000 |
| 00816042013119 | K161738 | 000 |
| 00816042013102 | K161738 | 000 |
| 00816042013096 | K161738 | 000 |
| 00816042013089 | K161738 | 000 |
| 00816042013072 | K161738 | 000 |
| 00816042013065 | K161738 | 000 |
| 00866457000372 | K161738 | 000 |
| 00866457000310 | K161738 | 000 |
| 00866457000303 | K161738 | 000 |
| 00858538007301 | K161738 | 000 |
| 00816042013645 | K161738 | 000 |