The following data is part of a premarket notification filed by Akers Biosciences, Inc. with the FDA for Breath Alcohol Check .02 And Breathscan .02 Detection Systems.
| Device ID | K062971 |
| 510k Number | K062971 |
| Device Name: | BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | Akers Biosciences, Inc. 201 GROVE RD. Thorofare, NJ 08086 |
| Contact | Barbara A Bagby |
| Correspondent | Barbara A Bagby Akers Biosciences, Inc. 201 GROVE RD. Thorofare, NJ 08086 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2006-12-18 |
| Summary: | summary |