The following data is part of a premarket notification filed by Diagnostic Devices Inc. with the FDA for Prodigy Voice Blood Glucose Monitoring System.
| Device ID | K073118 |
| 510k Number | K073118 |
| Device Name: | PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | DIAGNOSTIC DEVICES INC. 4F, 88, SEC. 1, KWANG FU ROAD San Chung, Taipei, TW 241 |
| Contact | Erica Li |
| Correspondent | Erica Li DIAGNOSTIC DEVICES INC. 4F, 88, SEC. 1, KWANG FU ROAD San Chung, Taipei, TW 241 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-05 |
| Decision Date | 2008-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384841732000 | K073118 | 000 |
| 00384841518505 | K073118 | 000 |
| 00038481518505 | K073118 | 000 |