The following data is part of a premarket notification filed by The Ashley Collection, Inc. with the FDA for Key Ring Alcohol Breathalyzer.
| Device ID | K082086 |
| 510k Number | K082086 |
| Device Name: | KEY RING ALCOHOL BREATHALYZER |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | THE ASHLEY COLLECTION, INC. 600 WEST 57TH ST. New York, NY 10019 |
| Contact | Robert Goldy |
| Correspondent | Robert Goldy THE ASHLEY COLLECTION, INC. 600 WEST 57TH ST. New York, NY 10019 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-23 |
| Decision Date | 2008-12-19 |
| Summary: | summary |