The following data is part of a premarket notification filed by Akers Biosciences, Inc. with the FDA for Breathscn Pro.
| Device ID | K102338 |
| 510k Number | K102338 |
| Device Name: | BREATHSCN PRO |
| 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 | 2010-08-18 |
| Decision Date | 2011-01-12 |
| Summary: | summary |