The following data is part of a premarket notification filed by Pas Systems International, Inc. with the FDA for Pas Alcovisor Mars, Pas Alcovisor Satellite.
| Device ID | K123470 |
| 510k Number | K123470 |
| Device Name: | PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | PAS SYSTEMS INTERNATIONAL, INC. 1616 PRINCESS ANNE STREET Fredericksburg, VA 22401 |
| Contact | Jarel R Kelsey |
| Correspondent | Jarel R Kelsey PAS SYSTEMS INTERNATIONAL, INC. 1616 PRINCESS ANNE STREET Fredericksburg, VA 22401 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2013-04-29 |
| Summary: | summary |