The following data is part of a premarket notification filed by Skyfine Inc. Limited with the FDA for Alcodigital Breathalyzer, Model At576, At577, At578, At579.
| Device ID | K091714 |
| 510k Number | K091714 |
| Device Name: | ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | SKYFINE INC. LIMITED NO.45, MINSHENG RD., DANSHUI TOWN( INNOVATION& INCUBATION C Taipei County, TW 251 |
| Contact | Michael Lee |
| Correspondent | Michael Lee SKYFINE INC. LIMITED NO.45, MINSHENG RD., DANSHUI TOWN( INNOVATION& INCUBATION C Taipei County, TW 251 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-10 |
| Decision Date | 2009-11-18 |
| Summary: | summary |