The following data is part of a premarket notification filed by Soberlink Healthcare Llc with the FDA for Soberlink Cellular Device And Sober Sky Web Portal.
| Device ID | K160613 |
| 510k Number | K160613 |
| Device Name: | Soberlink Cellular Device And Sober Sky Web Portal |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | SOBERLINK HEALTHCARE LLC 16787 BEACH BLVD #211 Huntington Beach, CA 92647 |
| Contact | Jenna Costa |
| Correspondent | Elisa Maldonado-holmertz OBELIX CONSULTING LLC 12416 FAIRFAX RIDGE PLACE Austin, TX 78738 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-03 |
| Decision Date | 2016-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B901GSM2REFURB0 | K160613 | 000 |
| B90111 | K160613 | 000 |
| B90108 | K160613 | 000 |
| B90109 | K160613 | 000 |
| B90106 | K160613 | 000 |
| B90107 | K160613 | 000 |
| B90101 | K160613 | 000 |
| B90102 | K160613 | 000 |
| B90103 | K160613 | 000 |
| B90104 | K160613 | 000 |
| B90105 | K160613 | 000 |
| B901CONNECT0 | K160613 | 000 |
| B901CONNECTREFURB0 | K160613 | 000 |
| B901GSM1REFURB0 | K160613 | 000 |
| B901GSM20 | K160613 | 000 |
| B90110 | K160613 | 000 |